BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2748017 · Received September 7, 2012

    Report

    Report Number
    1314492-2012-00265
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Report Date
    August 9, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION IT WAS OBSERVED THAT WHEN THE #2 (DEF) KEY IS PRESSED AN OUTPUT OF THE 3RD SOFT KEY WILL OCCUR. IT WAS ALSO OBSERVED THAT WHEN THE #3 (GHI) KEY IS PRESSED AN OUTPUT OF THE 4TH SOFT KEY WILL OCCUR. ALL OTHER KEYS PERFORMED AS EXPECTED. FURTHER ENGINEERING EVALUATION FOUND THE METAL OXIDE VARISTORS (MOVS) ON THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB) TO HAVE HIGH LEAKAGE CURRENT, WHICH RESULTED IN A KEYPAD OUTPUT RESPONSE ANOMALY. THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP KEYPAD IS "BAD."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1