BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3853802 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18169
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED BETWEEN JANUARY 7, 2013 AND JANUARY 8, 2013. EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE PATIENT CONTROL MODULE (PCM) UNIT WAS ATTACHED TO THE INFUSOR AND VISUAL INSPECTION SHOWED NO SIGNS OF PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED PROBLEM. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND THE AVERAGE DISPENSED VOLUME OF THE PCM UNIT WAS FOUND TO BE WITHIN SPECIFICATION. THE PCM WAS CONNECTED TO THE INFUSOR AND EVERY FIFTEEN MINUTES THE PCM BUTTON WAS PRESSED AND 0.5ML OF FLUID WAS DISPENSED. THE SAMPLE EVALUATION FOUND THE PCM TO BE WITHIN SPECIFICATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BASAL/BOLUS INFUSOR OVERINFUSED. THIS OCCURRED DURING INFUSION OF 60ML MORPHINE AND SALINE (NON-BAXTER PRODUCTS). THE EXPECTED THERAPY TIME WAS 5 DAYS, BUT THE ACTUAL INFUSION COMPLETED IN 2 DAYS AND 3.5 HOURS. THE REPORTER STATED THAT A PATIENT CONTROL MODULE (PCM) 0.5ML WAS BEING USED WITH THE DEVICE, AND ITS MEDICATION DEMAND BUTTON WAS PRESSED THREE TIMES DURING INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332703 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A014

    Patients

    Seq Age Sex Outcome Treatment
    1 MORPHINE| BASAL/BOLUS INFUSOR| NORMAL SALINE