BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1875248 · Received October 19, 2010

    Report

    Report Number
    6000001-2010-04293
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE EVALUATION IS IN PROGRESS. 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. THE DEVICE HAS NOT BEEN SERVICED BY BAXTER PRIOR TO THIS EVENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. 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 HAD INFUSION ALARMS OCCUR DURING AN ACCURACY TEST. THE EVENT OCCURRED DURING BIOMEDICAL TESTING. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING INITIAL PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT AFTER SHORTLY STARTING TO INFUSE, THE DEVICE WENT INTO CONSTANT ALARM WHICH CAUSED AN INTERRUPTION DURING DELIVERY. 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