BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1823098 · Received September 1, 2010

    Report

    Report Number
    6000001-2010-02921
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND EVALUATED BY BAXTER. THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. THE ASSIGNABLE CAUSE WAS OUT OF ADJUSTMENT END BLOCK. THE OCCLUSION ALARM WAS RECALIBRATED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A INFUSOR PUMP WITH A CONDITION OF 'OCCLUSION ERROR AND CANNOT GET PAST ERROR'. THERE WAS A FALSE ALARM. THIS CONDITION OCCURRED DURING PROGRAMMING/SETUP. THE AREA WHERE THIS EVENT OCCURRED IS AMBULATORY CARE. 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 6461500 INFUSOR PUMP (1 LABEL) PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1