BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSYRINGE INFUSION PUMP MODEL AS50

    MDR report key: 1024079 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-03643
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    December 7, 2006
    Report Date
    January 29, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE HAS BEEN REQUESTED FOR EVALUATION. IF DEVICE IS RECEIVED AND AN EVALUATION PERFORMED, A FOLLOW-UP MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE RECEIVED MEDWATCH FROM FDA. CUSTOMER REPORTED TO FDA AN OVERINFUSION THAT OCCURRED ON THIS AS50 PUMP. PREMATURE INFANT WITH GASTROSCHISIS WAS RECEIVING REPLACEMENT OF GASTRIC CONTENTS VIA THE AS50 PUMP. THE PUMP WAS PROGRAMMED TO ADMINISTER FOURTEEN ML OVER A TWELVE HOUR PERIOD. THE PUMP ALARMED TWENTY TO TWENTY-FIVE MINUTES LATER. PUMP INDICATED THIRTEEN ML HAD BEEN ADMINISTERED. NO PATIENT INJURY HAS BEEN REPORTED AT THIS TIME. PUMP IS CURRENTLY SEQUESTERED IN THE CLAIMS DEPARTMENT AT THE CUSTOMERS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSYRINGE INFUSION PUMP MODEL AS50 INFUSION PUMP FRN BAXTER HEALTHCARE N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO