BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3896559 · Received January 16, 2014

    Report

    Report Number
    1314492-2014-03550
    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
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OUT OF SPEC IN RELATION TO THE REPORTED SYMPTOMS, WHICH WAS REPRODUCED. SYSTEM ERROR 322 ALARM WERE CONFIRMED AND WERE DETERMINED TO BE CAUSED BY A LOOSE UPPER LATCH SWITCH BRACKET. THE UPPER AUXILIARY ASSEMBLY, WHICH CONTAINS THE LOOSE UPPER LATCH SWITCH BRACKET, WAS REPLACED. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43208 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1