BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMBI SET

    MDR report key: 5096467 · Received September 21, 2015

    Report

    Report Number
    8030665-2015-00438
    Event Type
    Death
    Date Received
    September 21, 2015
    Date of Event
    August 23, 2015
    Report Date
    August 24, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. RETURN SAMPLES ARE NOT EXPECTED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE REVIEW: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE MANUFACTURER WITH THE LOT NUMBER OF THE COMBISET USED IN THE REPORTED EVENT. AS NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT, A RECORD REVIEW WAS PERFORMED ON EACH OF THE LOT NUMBERS SHIPPED TO THE COMPLAINANT IN THE THREE MONTHS LEADING UP TO THE REPORTED EVENT. THE RECORD REVIEW FOUND TWO LOT NUMBERS SHIPPED TO THE CUSTOMER DURING THAT TIME PERIOD. THE BATCH PRODUCTION RECORDS FOR THESE LOTS WERE REVIEWED. THE BATCH RECORDS CONFIRMED THAT RELEASED PRODUCT MET SPECIFICATIONS; AND DOCUMENTED MANUFACTURING PROCESS CONTROLS WERE WITHIN SPECIFICATION. PER THE DOCUMENTED PRODUCT INVESTIGATION, THERE WAS NO INDICATION THAT THE FRESENIUS COMBISET CAUSED, CONTRIBUTED TO OR WAS A FACTOR IN THE REPORTED EVENT. SYSTEM LEVEL REVIEW OF THE 2008K MACHINE AND CONCOMITANT PRODUCTS FOUND THAT THERE WAS NO INFORMATION AVAILABLE TO CONCLUDE THAT THE PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. ALTHOUGH REQUESTED, MEDICAL RECORDS WERE NOT RECEIVED.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN (BMT) CALLED TECHNICAL SUPPORT AND REPORTED THAT A PT HAD PASSED AWAY WHILE UNDERGOING HEMODIALYSIS TREATMENT. THE BMT STATED THAT THE MACHINE WAS RUNNING NORMALLY AND HAD NO ALARMS. FOLLOW UP WAS PERFORMED WITH THE BMT AND THE REGISTERED NURSE (RN). ACCORDING TO THE BMT, HE CONFIRMED THERE WAS NO MACHINE MALFUNCTION FOUND. TO THE BEST OF HIS KNOWLEDGE, THE MACHINE IS BACK IN SERVICE WITHOUT ISSUE. THEY DID NOT HAVE A FRESENIUS REGIONAL EQUIPMENT SPECIALIST COME OUT. ACCORDING TO THE RN, THIS FEMALE PT ((B)(6)) WITH HISTORY OF CARDIAC DISEASE, WAS BEING DIALYZED IN THE HOSPITAL'S INTENSIVE CARE UNIT. SHE REPORTED THE PT'S PROGNOSIS WAS POOR PRIOR TO THE HEMODIALYSIS TREATMENT. APPROXIMATELY TWO HOURS INTO HER FOUR HOUR TREATMENT, THE PT "BEGAN BRADYING DOWN" (HER HEART RATE BEGAN DROPPING). AT THAT TIME, THE RN DISCONTINUED THE TREATMENT AND DID NOT RETURN THE PT'S BLOOD. THE PT, WHO HAD A DO NOT RESUSCITATE ORDER, EXPIRED APPROXIMATELY ONE HOUR LAGER. THE RN STATED THE MACHINE PASSED ALL TESTS PRIOR TO THE TREATMENT. THERE WERE NO ALARMS OR MALFUNCTIONS. ADDITIONALLY, NO MALFUNCTIONS WERE ALLEGED REGARDING THE CONCOMITANT PRODUCTS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623414 COMBI SET FJK FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death