BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1920621 · Received December 13, 2010

    Report

    Report Number
    6000001-2010-05761
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K855377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. THE ASSIGNABLE CAUSE WAS A FAULTY MPU (MICROPROCESSING UNIT) BOARD. THE MPU BOARD HAS BEEN REPLACED. ADDITIONAL: A SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND THE DEVICE HAS NOT BEEN PREVIOUSLY SERVICED PRIOR TO THIS EVENT. BAXTER HAS PERFORMED A DEVICE HISTORY REVIEW AND THERE WERE NO OBSERVATIONS NOTED DURING THE MANUFACTURING OF THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT WHEN THE DEVICE IS TURNED ON IT STOPS WHEN IT GETS TO THE BOLUS. A NONDELIVERY OCCURRED. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE EVENT OCCURRED DURING PROGRAMMING/SET-UP IN THE OPERATING ROOM. THERE IS NO FURTHER COMPLAINT INFORMATION 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