BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1172759 · Received September 22, 2008

    Report

    Report Number
    6000001-2008-00556
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED IN BAXTER ON SEPTEMBER 22, 2008, AND AN EVALUATION IS BEING PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED, WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED TO LARGO CUSTOMER SERVICE A PUMP WITH AN ERROR M046035 CODE, WHICH CAUSED THE INFUSION TO STOP DURING PATIENT USE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS50 INFUSION PUMP 80FPA FPA BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1