BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2911179 · Received December 7, 2012

    Report

    Report Number
    1314492-2012-00495
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND A FLOW RATE TEST WAS PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE AND THE DEVICE WAS FOUND TO DELIVER WITHIN SPEC. ADD¿L FLOW RATE TESTS WERE PERFORMED WITH THE UNIT PASSING. REVIEW OF THE DEVICE HISTORY LOG FOUND THAT ON THE LAST DAY THAT THE PUMP WAS IN USE, TWO INFUSIONS WERE PROGRAMMED; HOWEVER, SIGMA WAS UNABLE TO OBTAIN ANY ADD¿L EVENT DETAIL AND NO MALFUNCTION COULD BE IDENTIFIED. THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DELIVERED (MEDICATION TWICE AS FAST AS THE PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER ALSO REPORTED THAT THERE WAS NO PT INJURY.

    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