BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1823054 · Received September 1, 2010

    Report

    Report Number
    6000001-2010-02920
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K945942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "DOWNSTREAM OCCLUSION TOO HIGH". (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF "DOWNSTREAM OCCLUSION TOO HIGH" WAS CONFIRMED AND DUPLICATED. THE ROOT CAUSE WAS NOT IDENTIFIED. NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME SINCE THIS IS A BAXTER OWNED DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSOR PUMP TO BAXTER WITH A CONDITION OF "DOWNSTREAM OCCLUSION TOO HIGH." THIS CONDITION OCCURRED DURING BIO-MED TESTING. THE AREA WHERE THIS EVENT OCCURRED IS BIOMEDICAL LAB. THERE WAS NO PATIENT INJURY 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