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Based on record review and interview, the hospital failed to ensure a newborn was safe from accidents involving falls, resulting in a skull fracture and a subdural hematoma. This affected one of ten patients.

See A0144

Based on record review and interview, the hospital failed to ensure a newborn was safe from accidents involving falls, resulting in a skull fracture and a subdural hematoma. This affected one (Patient #1) of ten patients.

Findings include:

Record review revealed Patient #1 was diagnosed at 23 weeks gestation with left ventricular dilation with severe left ventricular dysfunction and endocardial fibroelastosis (EFE) so Patient #1's mother was followed by the Fetal Center. On 03/04/25 at 8:29 AM the patient was delivered via cesarean section at 37 6/7 weeks gestation at the hospital with an Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score of eight at one minute of life and nine at five minutes of life (a normal score is between seven and nine). Following the delivery, Patient #1 was vigorous with appropriate perfusion and weighed six pounds and 15.5 ounces with a head circumference was 32.2 centimeters (cm). An umbilical venous catheter was placed and Patient #1 was admitted to the Cardiothoracic Intensive Care Unit (CTICU) with recommendations for a cardiac catheterization as physicians noted this would help them better understand Patient #1's hemodynamics.

On 03/12/25 at 11:33 AM Patient #1 underwent a cardiac catheterization which revealed a thrombus to the right femoral artery. The patient was started on Lovenox (blood thinner). The cardiologist, Staff M, noted "Overall reassuring hemodynamics and normal cardiac index." On 03/15/25 at 11:54 AM Patient #1 was transferred to the Cardiac Stepdown unit.

Review of Patient #1's medical record revealed Patient #1's nurse and the PCA, Staff E were in the room at 7:21 PM.

Review of the nursing note dated 03/25/25 at 9:40 PM by the Registered Nurse (RN) Staff stated she was notified by another RN, Staff G, that Patient #1 had fallen approximately three to four feet from the crib to the floor onto her left side. When Staff F arrived to the room, Patient #1 was accompanied by the Charge Nurse, Staff G and the Medical Doctor, Staff H. An assessment of Patient #1 revealed localized edema to left side of head and periorbital swelling. The neurological assessment was appropriate with equal and reactive pupils. Patient #1 was responding appropriately with purposeful movement and agitation but was not consolable. A complete bone survey X-ray and head CT were ordered at this time by Staff H. Staff F transported the patient to scans accompanied by an additional RN. Due to scan results communicated with the team, Staff F expressed concerns for the patient needing close monitoring. Staff H notified Patient #1's responsible parties of the results of the scans.

Review of physician notes by Staff H dated 03/25/25 at 10:05 PM documented he was called to Patient #1's beside at 9:45 PM to assess the patient after being informed that at approximately 9:30 PM, while a Patient Care Assistant (PCA), Staff E, was in the room caring for Patient #1, they left facing guard rail was down. The telemetry box was in Staff E's pocket and the leads were still attached to Patient #1 while she was laying down in the crib. Staff E moved away from the crib to access the workstation by the bed, pulling the patient out of the crib by the telemetry wires causing her to fall to the floor on her left side. Patient #1 was returned to the bed. Since this time she has been reportedly been irritable and crying. Upon Staff H's arrival at 9:50 PM he assessed the patient. Patient #1 was crying but intermittently consoled, with some redness and swelling to the left posterior parietal scalp. The physician noted this was likely a fall of three to four feet and given this they would pursue computed tomography (CT) of the head to rule out intracranial/skull trauma. Patient #1's mother was called at 10:04 PM to inform her that the patient had fallen. Immediate concern was expressed and the phone was hung up. Attempted to call again at 10:05 PM with no answer.

Review of Patient #1's CT scan without contrast of the head dated 03/25/25 at 11:07 PM revealed a minimally depressed left parietal bone fracture with extra-axial hemorrhage deep to the fracture overlying the left cerebral convexity, subdural versus epidural. Left parietal scalp hematoma overlying the fracture.

On 03/25/25 at 11:48 PM the patient was transferred back to CTICU.

Review of a Hematology Oncology Consult note by Staff T, dated 03/26/25 revealed they received a call from Patient #1's primary team regarding patient with extra-axial hemorrhage after falling three to four feet on 03/25/25 from the crib and a head CT revealed a parietal bone fracture and accompanying small extra-axial hemorrhage with questions regarding dosing for possible protamine reversal as the patient is on Lovenox. He noted Patient #1 has dilated cardiomyopathy and developed a right lower extremity arterial thrombus after a cardiac catheterization performed on 03/12/25. The physician noted he would continue to monitor and determine definitively tomorrow whether surgical intervention warranted. He noted the patient had no other bleeding and the Lovenox, last received eight hours ago was being held.

Review of the echocardiogram completed on 03/27/25 at 2:40 PM revealed results were findings of new moderately or severely depressed right or left ventricular systolic function.

Review of progress notes by RN Staff V documented on 03/28/25 at 5:45 AM, Patient #1 coded and at 6:00 AM the patient was intubated with placement verified due to apnea and respiratory failure. Review of another progress noted by RN Staff W documented on 03/28/25 at 6:53 AM Patient #1 coded again and an emergent median sternotomy allowing central extracorporeal membrane oxygenation (ECMO, a life-support system that provides temporary support for the heart and/or lungs when these organs are unable to function properly) cannulation at 7:29 AM.

Review of the note by the ECMO surgeon, Staff DD, dated 03/28/25 at 8:00 AM documented Patient #1 was a three week old baby that had a prenatal diagnosis of cardiomyopathy, such that she was born at the Heart Center at Nationwide Children's Hospital via planned cesarean section with a separate operating room available for the baby if she required emergent mechanical cardiopulmonary support. The surgeon noted fortunately, the baby initially did very well, requiring no mechanical support, and eventually only oral heart failure medicines. She was improving on the step-down unit and then had an unfortunate fall, requiring observation in the Cardiothoracic Intensive Care Unit. Overnight, she had some unusual findings necessitating a head CT scan. Upon return from this advanced imaging, she had worsening respiratory distress, and then a sudden cardiopulmonary arrest. Despite being a witness arrest in the Cardiothoracic Intensive Care Unit with active CPR and resuscitation efforts, the baby was not able to be resuscitated. At the request of the CT ICU team and the family, the decision was made to proceed with ECMO cannulation. Given that the baby was recovering from a potential brain injury, it was felt that compromising a carotid artery for cannulation would be suboptimal. Plus the respiratory therapy team was having some challenges with the endotracheal tube and finally, the potential need for longer-term central ventricular assist device. Therefore, the decision was made to proceed with an emergent median sternotomy allowing central ECMO cannulation.

Review of provider progress notes dated 03/28/25 at 10:57 AM revealed Physician Staff X noted Patient #1 was on ECMO, intubated, sedated, with mottling in all four extremities. No palpable pulses on either lower extremity.

Review of a neurology note dated 03/28/25 at 11:10 AM revealed the neurologist physician, Staff J, noted Patient #1 was a three week old baby girl with prenatally diagnosed dilated cardiomyopathy who was admitted to the CTICU post-natally for cardiac catheterization (3/12/25) and cardiac MRI. The hospital course was complicated by a fall from a crib resulting in a left parietal skull fracture and left parietal scalp hematoma, as well as worsening of ventricular function noted by echocardiogram completed on 03/27/25. The physician noted on the morning on 03/28/23 at around 6:00 AM, Patient #1 was initially tachycardic but then had bradycardia in to the high 60's. The patient required bagging and then intubation.

Review of a provider progress note dated 03/28/25 at 5:23 PM revealed Staff J reviewed Patient #1's initial head CT from the fall and then from this morning post-intubation and there is a small subdural hematoma over the left parietal lobe, with associated skull fracture and cephalohematoma. Review of the CT scan dated 03/29/25 revealed the patient had increased intracranial hemorrhage, with new dense hemorrhage now seen layering within posterior interhemispheric fissure and along bilateral tentorial leaflets, with increased thickness of extra-axial hemorrhage over left parietal lobe also noted. The bilateral lateral ventricles and third ventricle are slightly increased in size, and the left parietal bone fracture morphology is stable.

On 03/29/25 at 1:17 AM, the neurologist physcian, Staff Y noted Patient #1 had seven electrographic seizures on 03/28/25 at 11:50 PM and continued having seizures after administering phenobarbitol (medication used to control seizures). ECMO adjustments were made and the patient was taken to CT. The patient continued to have seizures in longer increments and Versed (treats epilepsy) was administered.

On 03/29/25 at 11:39 AM, RN Staff Z noted Patient #1's pupil sizes were different between the left and right eye upon assessment with pupilometer. The provider was notified.

Review of a head CT without contrast on 03/30/25 revealed findings consistent with diffuse cerebral hypoxic ischemic injury. Loss of cerebral gray-white matter differentiation and diffuse edema. Areas of hyperattenuation throughout the cortex could represent some degree of laminar necrosis. However, a small amount of intraparenchymal hemorrhage cannot be excluded. Basal ganglia also appear indistinct, likely involved as well.

Review of Neurology Notes revealed on 03/30/25 at 4:06 PM, Staff J noted Patient #1 continued to have electrographic seizures overnight requiring treatment although there appeared to be a decrease in the frequency of seizures. Electroencephalogram (EEG) background otherwise overall suppressed without normal background features. On neurological examination, the patient continues to have pupillary response to light but otherwise no reactivity on examination. CT of the head obtained today demonstrated extensive hypoxic ischemic injury throughout the cerebral cortex and no significant change in the side of the left frontal subdural hematoma. Clinical picture overall remains concerning for significant hypoxic-ischemic injury to Patient #1's brain during her prolonged cardiac arrest. The provider discussed with the family that the injury that has already occurred to Patient #1's brain could not be reversed and the ultimate goal with management of the seizures is to prevent additional injury to her brain. Based on the degree of injury we can see on Patient #1's CT of the head and the abnormalities on her EEG, the patient is going to have a degree of neurodevelopment impairment with the possibility that she will not be able to communicate, ambulate, or possibly even eat or breathe without technological assistance. The family lovingly shared that they did not want Patient #1 to suffer or experience any pain. At that time, family wanted to continue to give the patient time to see how she recovers. The physician noted they would continue to monitor the patient on continuous EEG with the plan to treat prolonged seizures or electrographic status epilepticus with >12 minutes of seizure burden per hour, and noted they would also will be judicious with seizure management given that she also has required increased blood pressure support.

Review of a Social Work note dated 03/30/25 at 4:45 PM revealed Licensed Social Worker (LSW) Staff BB noted Patient #1 coded on 03/28/25 and was subsequently placed on ECMO. Staff BB noted Patient #1's most recent head MRI showed concern for a significant hypoxic injury, likely secondary to her cardiac arrest on 03/28/25. Staff BB noted the MRI results revealed findings consistent with diffuse cerebral hypoxic ischemic injury, loss of cerebral gray-white matter differentiation and diffuse edema. Staff BB noted areas of hyperattenuation throughout the cortex could represent some degree of laminar necrosis. However, a small amount of intraparenchymal hemorrhage could not be excluded. Basal ganglia also appeared indistinct, likely involved as well. Staff BB, Spiritual Care, the Charge RN, and the Neurology team to include Staff J met with Patient #1's mom and dad to discuss these results. The doctor explained that this injury could not be reversed and shared concern that Patient #1 would not be able to talk, ambulate or potentially breathe on her own. The parents stated that they did not want Patient #1 to be in pain or to suffer, but they were not ready to give up on her yet and wanted to see how she does in the next couple of days.

Review of a physician progress note dated 03/30/25 at 5:56 PM revealed after carefully considering the information provided from neurology concerning Patient #1's condition, the family wished to withdraw support after the patient was baptized.

On 03/31/25 at 3:38 PM after Patient #1 was baptized, the order was placed to allow natural death.

Review of physician progress notes dated 03/31/25 at 7:22 PM revealed Physician Staff CC noted Patient #1 was extubated per her parents request to allow them to hold her. When the family was ready, and the patient was in the mother's arms, a one hour bolus of morphine (pain medicine) and versed (sedative) were administered, after which the ECMO flow was stopped and circuit clamped and cut away from the patient ending ECMO support. The child was initially comfortable appearing without respiratory effort or distress and no evidence of pain. Approximately 10 minutes later the patient had evidence of distress and an additional one hour bolus of both morphine and versed were given. Patient #1 developed bradycardia with cessation of support and was pronounced at 7:50 PM.

Review of the Autopsy-Anatomic Preliminary Report dated 04/01/25 revealed the following anatomic preliminary diagnoses; congenital cardiomyopathy, a palpable left parietal subgaleal soft tissue mass consistent with a hematoma, minimally depressed left parietal skull fracture (status post fall out of bed), subcapsular hematoma on medial, inferior area of the left lobe of the liver, distended urinary bladder and, and slightly low-set and posteriorly rotated ears. Histopathology, detailed cardiopulmonary, microbiologic cultures, electron microscopy of the left ventricular myocardium and fibroblast cultures for possible future studies were pending.

Review of the Discharge Summary dated 03/31/25 revealed the preliminary cause of death was listed as dilated cardiomyopathy.

During an interview on 04/02/25 at 11:30 AM, Staff G revealed she responded to Patient #1's room on 03/25/25 at approximately 9:40 PM because Patient #1's assigned nurse was busy and she was near the telemetry monitor when the patient's oxygen saturations dropped. Staff G stated she went in the room and saw Staff E holding Patient #1. Staff G stated she asked Staff E to put Patient #1 in the bed so that she could assess her. She stated Patient #1's oxygen saturations were now okay, so she tried to swaddle the baby to calm her. The baby was still crying and she began to speak calmly to the baby. Staff E said "I think I can tell you why the baby is crying." Staff E said she put the telemetry monitor box in her pocket while she was feeding Patient #1. After the feeding she put Patient #1 back in the crib with the side rail down. She walked away to chart and dragged Patient #1 from the crib by the monitor wires to the floor. Patient #1 landed on her left side. Staff G stated she immediately assessed Patient #1's head and noted swelling. She stated they were unable to assess her pupil size because Patient #1 would not open her eyes. She then informed the charge nurse, Patient #1's nurse and the physician of the incident. She stated safety reports were completed on 03/25/25 by her and Staff E. She stated she was not sure what time Patient #1 fell out of bed as she was not called in because the newborn had fallen. She went in because Patient #1's oxygen saturations had declined and the monitor's alarm was sounding.

During an interview on 04/02/25 at 11:45 AM, with Staff O, the Clinical Staff Educator for the CTICU stated Staff E was a recent hire and was not scheduled to work again until the Tuesday following the incident, 04/01/25. Staff O stated Staff E has not been back to work since the incident on 03/25/25 with Patient #1.

During an interview on 04/02/25 at 3:15 PM, Staff P, the Clinical Leader Cardiac Stepdown, stated the unit uses only two types of cribs for newborns. Both of the beds have four sides (forming a rectangle) of bars and each side can be lowered. Staff P stated staff is instructed to have one hand on the patient or you must have the side rails up.