BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    MDR report key: 1897627 · Received November 12, 2010

    Report

    Report Number
    6000001-2010-04863
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEA
    PMA / PMN Number
    K051253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT A STAND ALONE PRODUCT AND WAS USED IN CONJUNCTION WITH A BAXTER BASAL/BOLUS INFUSOR (PRODUCT CODE J2C0216) DURING THIS EVENT. A SEPARATE MEDWATCH WILL BE SUBMITTED FOR THE BASAL BOLUS INFUSOR. THIS MEDWATCH IS BEING SUBMITTED FOR THE PATIENT CONTROL MODULE WATCH. 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. THE ASSIGNABLE CAUSE WAS AN OCCLUSION AT THE JUNCTION OF THE RESERVOIR AND TUBING, WHICH WAS CREATED DURING MANUFACTURING (WELDING PROCESS). PER INVESTIGATION, THE ROOT CAUSE OF THE OCCLUSION IS DUE TO OPERATION ERROR DURING WELDING OF THE JUNCTION. TO MITIGATE THE ISSUE, RE-TRAINING ON THE WELDING PROCESS WAS CONDUCTED TO PCM OPERATORS TO PREVENT RECURRENCE. ADDITIONAL: A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS DEVICE. 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 A PCM (PATIENT CONTROL MODULE) IN WHICH THE FACILITY SUSPECTED THAT A LEAK OCCURRED ON THE PCM. THE EVENT OCCURRED DURING PATIENT THERAPY AND THERAPY WAS INTERRUPTED. THE INFUSOR THAT THE PCM WAS CONNECTED TO WAS FILLED WITH ROPIVACAINE HYDROCHLORIDE HYDRATE. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON PUMP, INFUSION, PCA MEA BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1