FDA Adverse Event Death Summary report: N

ALARIS

MDR report key: 18083391 · Received November 7, 2023

Report

Report Number: 18083391
Event Type: Death
Date Received: November 7, 2023
Date of Event: November 4, 2022
Report Date: September 26, 2023
Manufacturer: CAREFUSION 303, INC.
Product Code: FRN
Adverse Event: Yes
Product Problem: Yes
Report Source: User Facility report
Reporter Location: MD
Reporter Occupation: RISK MANAGER
Health Professional: N

Narratives

Description of Event or Problem · 0

ELDERLY MALE WITH PMH OF HIV, DIABETES TYPE 2, HYPERTENSION, CORONARY ARTERY DISEASE CAME TO THE ED WITH A 6-WEEK HISTORY OF SHORTNESS OF BREATH WITH WORSENING DYSPNEA AND CHEST PAIN ON EXERTION. HE VOMITED TWICE IN THE ED AND EACH TIME HAD INCREASED WORK OF BREATHING AND HYPOXEMIA. HE WAS RESISTANT TO INTUBATION BUT CONSENTED AFTER THE SECOND EMESIS. THE PATIENT WAS GIVEN STANDARD MEDICATIONS TO OBTAIN AN ACCEPTABLE RASS SCORE. SHORTLY AFTER, HE LOST HIS PULSE. ROSC WAS SOON ACHIEVED. THE PATIENT LOST HIS PULSE AGAIN AND ROSC WAS AGAIN ACHIEVED. A NURSE BUMPED HIS ALARIS IV PUMP THAT WAS INFUSING EPINEPHRINE AND IT LOST CONNECTIVITY WITH THE CHANNEL AND SHUT DOWN. THE PATIENT AGAIN ARRESTED, AND ROSC WAS ACHIEVED. HE WAS TRANSFERRED TO THE ICU AND ARRESTED A FIFTH TIME. THE PATIENT ARRIVED IN RESPIRATORY DISTRESS AND WAS RESISTANT TO INTUBATION. HE MAY HAVE ASPIRATED TWICE AND CONSENTED TO INTUBATION AFTER THE SECOND EMESIS. HE WENT INTO CARDIAC ARREST FIVE TIMES ENDING IN DEATH. A NURSE BUMPED HIS IV PUMP CAUSING IT TO DISCONNECT FROM THE CHANNEL INFUSING EPINEPHRINE AND A CARDIAC ARREST OCCURRED. THE ALARIS PUMP AND CHANNEL DID NOT SECURELY CONNECT DUE TO MISSING AND MALFUNCTIONING PARTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1209597	ALARIS	PUMP, INFUSION	FRN	CAREFUSION 303, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	26645 DA	Male	Death