BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUP

    MDR report key: 3256565 · Received July 19, 2013

    Report

    Report Number
    1314492-2013-01500
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVALUATION COULD NOT REPRODUCE THE REPORTED SYMPTOM. THE DEVICE WAS PERFORMANCE TESTED FOR OVER 24 HOURS WITH NO OCCURRENCE OF SYSTEM ERROR 322. EIGHT OCCURRENCES OF EC 322 WERE CONFIRMED IN THE EHLR PORTION OF THE EVALUATION. ALTHOUGH THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM, THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE REPLACED, AS THEY ARE KNOWN TO CONTRIBUTE TO EC 322 ALARMS. 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 EXPERIENCED SYSTEM ERROR 322 - LINK SWITCH ERROR (LOW) ALARMS (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337344 SPECTRUM INFUSION PUP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1