BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3922297 · Received February 5, 2014

    Report

    Report Number
    1314492-2014-06246
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    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 REPORTED SYMPTOM SYSTEM ERROR 322 WAS CONFIRMED THROUGH THE HISTORY LOG. ALSO, PHYSICAL INSPECTION FOUND THAT THE LOWER LATCH SWITCH BRACKET SCREWS WERE LOOSE ALLOWING THE LOWER LATCH SWITCH TO MOVE IN AND OUT FROM THE LOWER DOOR LATCH. THE LOOSE SCREWS WILL TRIGGER AN INTERMITTENT OPEN/CLOSED SWITCH CONNECTION CAUSING THE REPORTED SYMPTOM. 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74670 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1