HospitalInspections.org

Based on observations, facility policy and procedure, Ryanodex Tools and Resources for Malignant Hyperthermia, Association of Perioperative Registered Nurses (AORN) article, and interviews, it was determined the facility failed to ensure medications were stocked at recommended levels and anesthesia medications were stored properly.

This deficient practice did affect one of one observation of surgery including Patient Identifier # 34, and had the potential to affect all patients receiving surgery at this facility.

Findings include:

Facility Policy: Malignant Hyperthermia

Policy Number: Not Listed

Revised: 11/20/24

...Purpose: To provide a well coordinated, rapid, effective response by the surgical team when a hypermetabolic crisis occurs...

I. Malignant Hyperthermia is a life threatening complication of the surgical patient that may be triggered by drugs commonly used in anesthesia (i.e., ... succinylcholine). ..

IV. Ryanodex and patient cooling are used to reverse the hypermetabolic process...

Pharmacy:

I. Will provide adequate supply of Ryanodex for Malignant Hyperthermia crisis.

Web Article: Ryanodex Tools and Resources for Malignant Hyperthermia

Copyright: 2025 Eagle Pharmaceuticals, Inc.

...6. How much Ryanodex should we stock?

MHAUS (Malignant Hyperthermia Association of the United States) recommends stocking a minimum of 700 mg (milligrams) dantrolene sodium, which is supplied in only 3 (three) vials of Ryanodex (dantrolene sodium) for injectable suspension (in contrast to the 36 vials required to obtain 700 mg with other dantrolene sodium IV (intravenous) products)...

AORN Article: Patient Safety

Published: 12/3/2013

...3. In and Out:

Succinylcholine and Rocuronium are to be refrigerated, but once removed, they can be stored at room temperature for specific periods of time (14 days for Succinylcholine; 60 days for Rocuronium, 28 days for opened Rocuronium)...

Once they're removed from refrigeration, they should be clearly marked with either the manufacturer's expiration date, or the appropriate date based on when they were removed, whichever comes first. They shouldn't be re-refrigerated...

1. A tour of the Surgery Department was conducted on 2/18/25 at 2:00 PM with Employee Identifier # 12, Emergency Department Director.

Two Ryanodex 250 mg vials were observed stored in the Pyxis medication storage unit. EI # 12 stated the hospital currently stocks Ryanodex for the treatment of malignant hyperthermia and there were no other vials available in the hospital.

An interview was conducted on 2/21/25 at 9:00 am with EI # 14, Pharmacist, who confirmed the facility failed to stock the recommended amount of medication for the treatment of Malignant Hypertention.

2. PI # 34 presented to the Surgery Department on 2/19/25 for an Esophagogastroduodenoscopy with Dilation.

An observation of the surgical procedure was conducted on 2/19/25 at 8:00 AM.

At 8:05 AM, EI # 17, Registered Nurse removed a tray containing Anesthesia medications including two 10 milliliter (ml) vials of Succinylcholine 200 mg/ml and two 5 ml vials of Rocuronium Bromide 50 mg/ml from the refrigerated medication storage unit and handed the medications to PI # 11, Certified Registered Nurse Anesthetist.

Review of PI # 34's Anesthesia Record dated 2/19/25 revealed Anectine (Succinylcholine) 160 mg was given at 8:15 AM.

At 9:30 AM, the medication tray containing one vial of Succinylcholine and two vials of Rocuronium Bromide was returned to the refrigerated medication storage unit per EI # 17.

An interview was conducted on 2/21/25 at 9:00 AM with EI # 14, who confirmed the Succinylcholine and Rocuronium were not labeled with the date they were removed from refrigeration and confirmed the vials were not to be re-refrigerated.