BEUDAMED
    FDA Adverse Event Death Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 2003374 · Received March 1, 2011

    Report

    Report Number
    6000001-2011-01440
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ONE UNIT WAS RECEIVED CONTAINING RESIDUAL FLUID IN THE BLADDER. UPON RECEIPT, THE UNIT WAS VISUALLY EXAMINED FOR ANY SIGNS OF ABNORMALITY; HOWEVER, NONE WERE FOUND. THEREAFTER, THE RESIDUAL FLUID IN THE BLADDER WAS DRAINED. ONCE DRAINED, 98.53 ML OF RESIDUAL FLUID WAS COLLECTED FROM THE BLADDER. SUBSEQUENTLY, AN ACCURACY FLOW TEST WAS CONDUCTED ON THE UNIT FOR 112 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE UNIT PRODUCED THE FOLLOWING FLOW RATE (ML/HR): CALCULATED = 1.91, NORMALIZED = 1.96. THE FLOW RATE WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE OF THE PRODUCT, 1.80 - 2.20 ML/HR. THEREFORE, THE REPORTED OVERINFUSION CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE CONFIRMED. A MANUFACTURING BATCH RECORD REVIEW WAS PERFORMED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. 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.

    Description of Event or Problem · 1

    THIS IS A REPORT RECEIVED ON (B)(6) 2011 BY BAXTER (B)(4). IT WAS REPORTED THAT A PATIENT BEING INFUSED WITH A 5 DAY INFUSOR RECEIVED THE INFUSION IN 3 DAYS INSTEAD OF 5 DAYS. THE INFUSOR WAS DISCONNECTED BEFORE THE THERAPY ENDED. THE PATIENT DIED; HOWEVER, THE DEATH WAS NOT DUE TO AN OVERINFUSION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 IS AS FOLLOWS: THE INFUSION BEGAN ON (B)(6) 2011 AT 9AM AND WAS REMOVED ON (B)(6) 2011 AT 6PM (SOME OF THE DRUG MIXTURE REMAINED IN THE RESERVOIR). THE INFUSION TIME WAS 57 HOURS. THE PATIENT DIED ON (B)(6) 2011 AT 8PM. THE INFUSOR WAS PLACED LOWER THAN THE PATIENT WAS LYING. THE DRUGS BEING INFUSED WERE MORPHINE 450MG, 10% XYLOCAIN 50ML, HALDOL 20MG, DEXAMETHASON 40MG, AND NORMAL SALINE UP TO 240ML. THE PATIENT'S DIAGNOSIS WAS CANCER OF THE UTERUS AND CERVIX WITH METASTASIS OF THE LUNGS AND BONES. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10F032

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death NORMAL SALINE| 10% XYLOCAIN 50ML| HALDOL 20MG| MORPHINE 450MG| DEXAMETHASON 40MG