BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 20988052 · Received December 20, 2024

    Report

    Report Number
    20988052
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 18, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION.
    Product Code
    PHC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD PRECEDEX INFUSION INITIATED IN POST ANESTHESIA CARE UNIT (PACU). PUMP WAS SET TO DELIVER 3.4 MILLILITERS PER HOUR AND WAS RUNNING FOR 45 MINUTES. NURSE REPORTED THAT MEDICATION BAG WAS DRY AND THEN QUESTIONED HOW A 100 MILLILITER BAG WAS DRY IN 45 MINUTES. PUMP SAID TOTAL GIVEN WAS 2 MILLILITERS. OPERATING ROOM (OR) PHARMACIST CAME TO BEDSIDE AND ENSURED THAT MEDICATION BAG HAD 100ML WHEN IT WAS DISPENSED. ANESTHESIA AND DOCTOR¿S TEAM NOTIFIED. PATIENT VITALLY STABLE BUT SEDATED. INTRAVENOUS (IV) PUMP TAKEN OUT OF SERVICE AND MARKED FOR REPAIR. PUMP WAS TESTED BY OUR HEALTH TECHNOLOGY MANAGMENT (HTM), WHO STATED THEY SENT THE PUMP TO BAXTER FOR REPAIR. THEIR TESTING: RAN 10% OVER ON A COUPLE OF DIFFERENT INFUSIONS. MANUFACTURER RESPONSE FOR INFUSION SAFETY MANAGEMENT SOFTWARE, SIGMA SPECTRUM INFUSION PUMP (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204240 SIGMA SPECTRUM INFUSION PUMP INFUSION SAFETY MANAGEMENT SOFTWARE PHC BAXTER HEALTHCARE CORPORATION. 35700BAX2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown