FDA Adverse Event Malfunction Summary report: N

ICU MEDICAL, INC.

MDR report key: 24829228 · Received April 9, 2026

Report

Report Number
24829228
Event Type
Malfunction
Date Received
April 9, 2026
Date of Event
April 1, 2026
Report Date
April 2, 2026
Manufacturer
ICU MEDICAL, INC.
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TN
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

INITIATION OF NEW ICU MEDICAL IV PUMPS ON [REDACTED]. FOUR ISSUES TO REPORT FROM [REDACTED]-THE NEXT DAY: 1. MODEL NUMBER: 40002-04-03. SERIAL NUMBER: [REDACTED]. IV PUMP ALARMED DISTAL AIR, AND TUBING APPEARED TO HAVE A SMALL AMOUNT OF AIR NEAR THE CASSETTE. WHEN CASSETTE DOOR WAS OPENED, THE CASSETTE DID NOT STAY CLAMPED AND STARTED TO BOLUS THE MEDICATION. THE MEDICATION WAS NOREPINEPHRINE. PT WAS AN IMMEDIATE POST-OP CABG [CORONARY ARTERY BYPASS GRAFT] AND THE INFUSION WAS GOING THROUGH A 9F INTRODUCER, THEREFORE THE NOREPINEPHRINE BOLUSED TO GRAVITY THROUGH THE LARGE BORE. UNKNOWN AMOUNTS OF MEDICATION WERE INFUSED DURING THIS. PT'S BP WENT FROM 96/49 TO THE 180-190S/90S/-100S RANGE AND LASTED APPROX. 4 MINUTES. DURING THIS TIME PT IMMEDIATELY REPORTED SEVERE PALPITATIONS AND PRESSURE ON HER CHEST WHICH DID NOT RESOLVE FOR 20-30 MINUTES. 2. MODEL NUMBER: 40002-04-03. SERIAL NUMBER: [REDACTED]. POST OP OPEN HEART HAD PROPOFOL PUT ON STANDBY BY PRIMARY NURSE. PRIMARY NURSE DISCONNECTED THE PROPOFOL LINE AND FLUSHED THE IV CLEAR. THE PROPOFOL DRIP LINE WAS HOOKED BACK UP TO THE PATIENT WITH THE IV PUMP STILL ON STANDBY. THE NURSE ASSESSED THE IV 15 MINUTES LATER AND THE IV WAS FULL OF PROPOFOL AND CONTINUED TO INFUSE. 3. MODEL NUMBER: 40002-04-03: SERIAL NUMBER: NO PUMP INFORMATION. IV PUMP ALARMING DOWNSTREAM AIR OCCLUSION. RN ATTEMPTED TO CLEAR THE ALARM, BUT ALARM WOULD NOT CLEAR. ICU MEDICAL REP ON SITE TO ASSIST WITH NEW PUMPS. ICU MEDICAL REP ALSO COULD NOT CLEAR THE ALARM AND HAD TO CLEAR THE PROGRAMING OF THE PUMP IN ORDER TO CLEAR THE ALARM. THE PATIENT WAS ON A HEPARIN DRIP AND HAD A DELAY GETTING IT RESTARTED DUE TO THE TROUBLESHOOTING. CLEARING THE PROGRAMMING OF THE PUMP TO CLEAR A DOWNSTREAM OCCLUSION IS NOT ACCEPTABLE WHEN WE RUN CRITICAL DRIPS. 4. MODEL NUMBER: 40002-04-03. SERIAL NUMBER: [REDACTED] . THE RIGHT CHAMBER FLOODED WITH IV FLUID: THE CHAMBER BROKE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
888287 ICU MEDICAL, INC. PUMP, INFUSION FRN ICU MEDICAL, INC. 400020403

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other