BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1230533 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88696
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    July 1, 2007
    Report Date
    July 2, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN REQUESTED EVALUATION. IF DEVICE IS RECEIVED, AND AN EVALUATION PERFORMED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INFUSION TESTING WAS PERFORMED ON THIS PUMP DURING BIOMED TESTING. TESTING WAS PERFORMED WITH A 20 ML BECTON DICKINSON SYRINGE. PUMP WAS PROGRAMMED TO ADMINISTER 125 ML/HOUR. PUMP ACTUALLY ADMINISTERED 127 ML/HOUR. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED ON THIS REPORT. NO PATIENT INVOLVEMENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS50 INFUSION PUMP 80FPA FPA BAXTER HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1