BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3896628 · Received January 16, 2014

    Report

    Report Number
    1314492-2014-03564
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS ALARMING FOR A SYSTEM ERROR 322. THERE WAS NO PT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43598 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1