BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3880035 · Received January 31, 2014

    Report

    Report Number
    1314492-2014-05284
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 6, 2014
    Manufacturer
    BAXTER HLTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF: (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE REPORTED SYMPTOM WAS CONFIRMED AND REPRODUCED. THE 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 NYLON SCREWS WILL TRIGGER AN INTERMITTENT OPEN/CLOSED SWITCH CONNECTION CAUSING THE REPORTED SYMPTOM OF EC 322. 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. THE UPPER AUXILIARY ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    A SYSTEM ERROR 322 ALARM WAS FOUND IN THE HISTORY LOG OF A PUMP THAT WAS EVALUATED DURING A SITE VISIT. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67466 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HLTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1