BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3853239 · Received January 23, 2014

    Report

    Report Number
    1314492-2014-04190
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 27, 2013
    Manufacturer
    BAXTER HEALTH CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED SYMPTOM OF "SYSTEM ERROR 322" WAS CONFIRMED AND REPRODUCED DURING EVALUATION. PHYSICAL INSPECTION FOUND THAT THE UPPER LATCH SWITCH BRACKET SCREWS WERE LOOSE ALLOWING THE UPPER LATCH SWITCH TO MOVE IN AND OUT FROM THE UPPER DOOR LATCH. THE LOOSE SCREWS WILL TRIGGER AN INTERMITTENT OPEN/CLOSED SWITCH CONNECTION CAUSING THE REPORTED SYMPTOM. THE UPPER AUXILIARY ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD A SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55404 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTH CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1