BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221673 · Received July 1, 2013

    Report

    Report Number
    1314492-2013-00955
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. THE EVAL CONFIRMED A SYSTEM ERROR 322 CAUSED BY A FAILED UPPER LATCH SWITCH. THE FAILED UPPER LATCH SWITCH 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 PUMP ALARMED FOR A SYSTEM ERROR 322 DURING AN INFUSION (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). IT IS UNK WHICH CARE AREA THE DEVICE WAS IN AT THE TIME OF THE ERROR, AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298115 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1