BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3891589 · Received January 31, 2014

    Report

    Report Number
    1314492-2014-05222
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. EVAL PRODUCED A SYSTEM ERROR 322 AS WELL AS CONFIRMED THIS ERROR MESSAGE THROUGH REVIEW OF THE EVENT HISTORY LOG. 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 SYSTEM. THE UPPER AUXILIARY ASSEMBLY 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

    DURING BAXTER'S EVAL OF A SPECTRUM PUMP, IT WAS FOUND TO ALARM FOR SYSTEM ERROR 322.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68925 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1