FDA Adverse Event Injury Summary report: N

BAXTER SPECTRUM IQ

MDR report key: 23839024 · Received December 18, 2025

Report

Report Number
MW5180807
Event Type
Injury
Date Received
December 18, 2025
Date of Event
August 10, 2025
Report Date
December 8, 2025
Manufacturer
BAXTER HEALTHCARE CORPORATION
Product Code
FRN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

BEDSIDE NURSE NOTED THAT HEPARIN INFUSION SEEMED TO BE DRIPPING AT A SLOWER RATE THAN EXPECTED. BAG, TUBING, AND PUMP CHANGED. DRIP APPEARED TO RUN FASTER FOLLOWING CHANGES DESPITE SAME PUMP SETTINGS. DRIPS WERE FALLING INTO DRIP CHAMBER SLOWER THAN EXPECTED. NO ISSUES NOTED WITH TUBING, OR HOW IT WAS SECURED IN THE PUMP. DURING THE TIME OF THE HEPARIN INFUSION PUMP, THERE WERE SEVERAL TIMES NOTED THAT VOLUME WAS ADDED TO THE PUMP. THE RATE WAS INCREASED SEVERAL TIMES PER PROTOCOL, PLUS HEPARIN BOLUSES ADMINISTERED ACCORDING TO HOSPITAL HEPARIN PROTOCOL DUE TO SUBTHERAPEUTIC HEPARIN 10A LEVELS. IN REVIEW OF THE LOG REPORT, THE PUMP REPORTED THAT A TOTAL VOLUME OF 523.6 ML WAS GIVEN BETWEEN THE CHANGE OF ONE BAG TO THE CHANGE OF THE NEXT BAG. IT IS UNKNOWN HOW MUCH VOLUME REMAINED IN THE ORIGINAL HEPARIN BAG. 1. LAB RESULT WAS 3RD SUBTHERAPEUTIC HEPARIN 10A LAB RESULT DURING THE TIME OF THE HEPARIN UNDERINFUSION. 2. THIS IS THE HEPARIN 10A LAB RESULT AFTER THE NURSE CHANGED THE PUMP, TUBING, AND MED. THE PATIENT IMMEDIATELY BECAME SUPRATHERAPEUTIC AND TOOK TIME TO RE-REGULATE HEPARIN RATE TO A SAFE LEVEL. PATIENT WAS ADMITTED FOR TRAUMA AND OUT OF HOSPITAL CARDIAC ARREST DUE TO ARRHYTHMIA. HEPARIN WAS A SIGNIFICANT PART OF THIS PATIENT'S THERAPY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2282197 BAXTER SPECTRUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 69 YR Male Other