BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR PUMP

    MDR report key: 1014063 · Received March 13, 2008

    Report

    Report Number
    6000001-2008-00156
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    March 5, 2008
    Report Date
    June 7, 2008
    Manufacturer
    BAXTER HEALTHCARE, PTE LTD.
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN REQUESTED FOR EVAL. WHEN THE PUMP HAS BEEN RECEIVED, AND AN EVAL HAS BEEN PERFORMED. A F/U REPORT WILL BE FILED. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED THAT THE DEVICE DID NOT DELIVER ANY OF THE UNSPECIFIED MEDICATION. THIS WAS FOUND DURING PT USE, WITH NO PT INJURY REPORTED OR MEDICAL INTERVENTION NEEDED. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFO, DETAILS WERE NOT AVAIL REGARDING ADD'L CONTACT INFO. NO ADD'L INFO IS AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP 80FRN FRN BAXTER HEALTHCARE, PTE LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1