BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1914789 · Received December 4, 2010

    Report

    Report Number
    6000001-2010-05517
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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). A TREND REVIEW HAS BEEN PERFORMED AND SIMILAR REPORTS HAVE BEEN RECEIVED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED TO LARGO CUSTOMER SERVICE THAT THE INFUSOR DEVICE CONSTANTLY ALARMED L02 DURING POWER UP IN THE SURGERY CENTER. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING BAXTER'S PRODUCT EVALUATION IT WAS DISCOVERED THAT THERE WAS A CONSTANT ALARM THAT OCCURRED WHILE THE DEVICE WAS RUNNING. 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