BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1932529 · Received December 18, 2010

    Report

    Report Number
    6000001-2010-05959
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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). 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR IN WHICH THERE WAS AN INTERMITTENT CONSTANT ALARM WHILE THE DEVICE WAS INFUSING. THE EVENT OCCURRED IN THE OPERATING ROOM. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE EVENT OCCURRED DURING PROGRAMMING/SET-UP. THERE IS NO FURTHER INFORMATION ASSOCIATED WITH THIS REPORT.

    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