BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1884312 · Received October 27, 2010

    Report

    Report Number
    6000001-2010-04558
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K945942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE SENT BACK TO BAXTER FOR EVALUATION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED TO BAXTER THAT AN AS50 INFUSION PUMP WITH A CONDITION OF "OVERINFUSION ON AN INFANT, THE EXPECTED INFUSION TIME WAS 1 HOUR BUT THE DEVICE INFUSED IN 30 MINUTES." THIS CONDITION OCCURRED DURING PATIENT THERAPY. THE PATIENT WAS INFUSED WITH GANCICLOVIR ANTIBIOTIC THAT WAS COMPOUNDED BY THE FACILITY. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS50 INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA