FDA Adverse Event Death Summary report: N

BD ALARIS IV PUMP WITH CHANNELS

MDR report key: 17135749 · Received June 14, 2023

Report

Report Number
MW5118402
Event Type
Death
Date Received
June 14, 2023
Report Date
June 6, 2023
Manufacturer
BD
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ALARIS IV PUMP CHANNELS SPONTANEOUSLY DISCONNECT FROM MAIN UNIT AND ARE INOPERABLE. SOMETIMES THE MEDICATION STOPS INFUSING AND SOMETIMES THE MEDICATION FREE FLOWS DOWN THE TUBING INTO THE PATIENT. AT OUR MEDICAL CENTER UCSD 2 PATIENT DEATHS WERE RESULTS OF PUMP FAILURE WHILE VASOPRESSORS WERE RUNNING AND THEY ALL SHUT OFF AND THE PT SUFFERED CARDIAC ARREST. ANOTHER PATIENT RECEIVED ACCIDENTAL RAPID BOLUS OF 20MEQ K+ BECAUSE THE PUMP FAILED AND THE MED FREE FLOWED INTO THE PATIENT. THIS PATIENT HAD CARDIAC ARREST BUT WAS RESUSCITATED. NURSES ACROSS THE HOSPITAL HAVE REPORTED THESE EVENTS TO OUR MANAGERS, DIRECTORS, AND EVEN OUR CNO, BIOMEDICAL ENGINEERING, EVERYONE. WE HAVEN'T RECEIVED NEW PUMPS AND OUR ADMINISTRATION IS SAYING IT IS NURSE ERROR. WE WANT TO AVOID ANY ADDITIONAL DEATHS/ADVERSE EVENTS. REFERENCE REPORT #MW5118401, #MW5118403.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2057300 BD ALARIS IV PUMP WITH CHANNELS PUMP, INFUSION FRN BD

Patients

Seq Age Sex Outcome Treatment
1 Unknown Required Intervention| D| L| S| H| O