BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT CONTROL MODULE WATCH, 12 PACK

    MDR report key: 1231403 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88374
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    May 3, 2007
    Report Date
    May 3, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION,
    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

    THE DEVICE INVOLVED IN THIS INCIDENT HAS BEEN REQUESTED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED, EVALUATION RESULTS WILL BE PROVIDED IN A FOLLOW UP REPORT. THE BATCH REVIEW WAS FOR LOT 06D051, WHICH REVEALED THAT THE LOT WAS PACKED OUT WITH PASSING RESULTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATING THAT THE PCM'S BUTTON DID NOT FUNCTION CORRECTLY SO THAT THE FLOW DID NOT STOP AT THE PCM. HENCE, THE MALFUNCTION IS REPORTED AGAINST THE PCM WITH THE INFUSOR AS A CONCOMITANT DEVICE. DEVICE EVALUATION RESULTS: ONE USED BASAL/BOLUS INFUSOR WAS RECEIVED WITH AN ATTACHED 0.5ML PATIENT CONTROL MODULE (PCM) CONTAINING NO SOLUTION. UPON RECEIPT, THE UNIT WAS VISUALLY EXAMINED FOR ANY SIGNS OF ABNORMALITY THAT MAY HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED OVERINFUSION, BUT NONE WERE FOUND. THE PCM WAS THOROUGHLY EXAMINED FOR ANY EVIDENCE OF DAMAGE, PARTICULARLY AT THE DEMAND BUTTON WHERE IT WAS REPORTED TO NOT FUNCTION CORRECTLY. HOWEVER, NO EVIDENCE OF DAMAGE WAS FOUND. PER PROCEDURE, A FLOW TEST WAS SUBSEQUENTLY PERFORMED ON THE INFUSOR FOR 19.2 HOURS AND A FUNCTIONAL TEST WAS ALSO CONDUCTED ON THE 0.5ML PATIENT CONTROL MODULE. AT THE END OF THE FLOW AND FUNCTIONAL TEST PERIOD, THE FOLLOWING RESULTS WERE OBTAINED FROM THE INFUSOR AND THE 0.5ML PATIENT CONTROL MODULE: INFUSOR: CALCULATED BASAL 0.5185 ML/HR, NORMALIZED (2.5%) 0.5315 ML/HR, SPECIFICATION RANGE 0.1375 - 05625. CALCULATED BOLUS 1.78 ML/HR, NORMALIZED (2.5%) 1.83 ML/HR, SPECIFICATION RANGE 1.75 - 2.25. 0.5ML PATIENT CONTROL MODULE: AVERAGE VOLUME DELIVERED = 0.508SPECIFICATION RANGE = 0.425 - 0.550ML. THE FLOW RATES OF THE INFUSOR AND THE AVERAGE DELIVERED VOLUME OF THE 0.5ML PATIENT CONTROL MODULE WERE FOUND TO BE WITHIN THE SPECIFICATION RANGE. FURTHERMORE, THE DEMAND BUTTON OF THE PCM FUNCTIONED PROPERLY DURING THE FUNCTIONAL TEST. THEREFORE, BASED ON THE FINDINGS, THE DEVICE PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    BAXTER-JAPAN RECEIVED A CUSTOMER REPORT IN WHICH THE DEVICE WAS OBSERVED TO BE INVOLVED IN AN OVERIFUSION INCIDENT DURING PATIENT USE. THE DEVICE WAS FILLED WITH AN UNKNOWN VOLUME OF MORPHINE HYDORCLORIDE AND AN UNKNOWN DILUENT. THE DURATION OF INFUSION IS UNKNOWN. THE NUMBER OF TIMES THE PCM BUTTON WAS USED IS UNKNOWN AT THIS TIME. THE TEMPERATURE DURING INFUSION IS 33 DEGREES CENTIGRADE. NO INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT CONTROL MODULE WATCH, 12 PACK 80MEA MEA BAXTER HEALTHCARE CORPORATION, NA 06D051

    Patients

    Seq Age Sex Outcome Treatment
    1