BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1934714 · Received December 21, 2010

    Report

    Report Number
    6000001-2010-06073
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. THE ASSIGNABLE CAUSE IS A DEFECTIVE MOTOR. THE MOTOR HAS BEEN REPLACED. ADDITIONAL: A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED BY BAXTER PRIOR TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A DEVICE HISTORY REVIEW WAS PERFORMED FINDING THAT THE DATA CARD HAS BEEN DISCARDED PER RETENTION PERIOD DOCUMENTED ON 20J 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY BEING EVALUATED BY BAXTER. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR PUMP WITH A CONDITION OF: "DURING TESTING IN THE BIOMED SHOP, THE LED (LIGHT-EMITTING DIODE) LIGHTS LIT UP. THE DEVICE ALARMED AND BECAME INOPERABLE AFTER POWER UP." THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING THE PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT THE PUMP WOULD RUN FOR A FEW SECONDS THEN STOP AND GO INTO CONSTANT ALARM WITH ALL 3 LEDS LIT. THERE WAS 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