BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RE-MANUFACTURED IPUMP

    MDR report key: 1082116 · Received July 25, 2008

    Report

    Report Number
    6000001-2008-00431
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEA
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS REQUESTED FROM THE REPORTING FACILITY. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED, AND THE RESULTS OF EVAL BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE BIOMED TECHNICIAN CALLED BAXTER PRODUCT SURVEILLANCE TO REPORT THAT THEY HAVE AN IPUMP AT THEIR FACILITY WITH INTERMITTENT FALSE AIR IN LINE ALARMS OBSERVED AT THEIR LABOR AND DELIVERY DEPARTMENT DURING PT USE. THE ALARM CAUSES THE PUMP TO STOP INFUSING. NO INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS REPORT. THE CUSTOMER SENT THE DEVICE BACK TO BAXTER FOR EVAL AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RE-MANUFACTURED IPUMP 80FRN MEA BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1