BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOFILTRATION UNIT BM11 + BM14

    MDR report key: 1933564 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07089
    Event Type
    Death
    Date Received
    December 20, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES GERMANY GMBH
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE REPORT RECEIVED FOR THE ONSITE EVALUATION OF THE BM14 COMPONENT OF THE BM25 DEVICE INVOLVED IN THE EVENT INDICATES THAT THE DEVICE PASSED THE SELF TEST. THE FILTRATE AND SUBSTITUTION PUMP DELIVERY WAS CHECKED AND PASSED. THE FILTRATE AND PRE-FILTER PRESSURES WERE ALSO CHECKED AND WERE BOTH FOUND TO BE WITHIN LIMITS. THE SUBSTITUTION AND FILTRATE SCALES WERE CHECKED AND FOUND TO BE ACCURATE. THE HEATER OPERATION WAS CHECKED AND FOUND TO BE ADEQUATE. THE VOLTAGE WAS CHECKED ON THE SECONDARY POWER SUPPLY AND WAS FOUND TO BE ADEQUATE. CALIBRATION, FUNCTIONAL SAFETY, AND ELECTRICAL SAFETY WERE ALL TESTED AND FOUND TO BE ADEQUATE. A SERVICE REPORT RECEIVED FOR THE ONSITE EVALUATION OF THE BM11 COMPONENT OF THE BM25 DEVICE INVOLVED IN THE EVENT INDICATES THAT THE SELF TEST PASSED. THE BLOOD PUMP WAS CHECKED AT 100 AND 200 AND THE RESULTS WERE WITHIN 1%. THE ARTERIAL AND VENOUS PRESSURES WERE CHECKED AND BOTH WERE WITHIN LIMITS. THE AIR AND BLOOD DETECTORS WERE CHECKED AND FOUND TO BE ADEQUATE. THE PRESSURE ALARMS WERE CHECKED AND ALSO FOUND TO BE ADEQUATE. THE CLAMP OPERATION WAS CHECKED AND FOUND TO BE ADEQUATE. THE VOLTAGE ON THE POWER SUPPLY WAS ALSO CHECKED AND FOUND TO BE ADEQUATE. THE EVALUATION WAS UNABLE TO FIND ANY FAULT WITH THE DEVICE. CALIBRATION, FUNCTIONAL SAFETY, AND ELECTRICAL SAFETY WERE ALL TESTED AND FOUND TO BE ADEQUATE.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS REVIEWED THE DEVICE HISTORY FILES OF THE INVOLVED DEVICES AND NO ISSUES WERE NOTED. THERE IS NO ELEMENT TO SUSPECT THE MACHINES CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) ON 03 DECEMBER 2010 FROM (B)(6) HOSPITAL VIA AN ACCOUNT MANAGER. IT WAS REPORTED THAT ON (B)(6) 2010 A FEMALE PATIENT PASSED AWAY WHILE RECEIVING TREATMENT ON A BM25 MACHINE, SERIAL NUMBER NOT CONFIRMED. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT THE PATIENT WAS BEING FILTERED USING A BM25 MACHINE AND WHILE ON TREATMENT THE PATIENT PASSED AWAY. DUE TO THE NATURE OF THE PATIENT?S ILLNESS, AN AUTOPSY WAS REQUESTED. THE MACHINE WAS PLACED UNDER QUARANTINE AND WAS MOVED TO THE BEREAVEMENT OFFICE BY THE CORONER. THE CORONER REQUESTED THAT THE MACHINE DOES NOT GET RELEASED UNTIL THE AUTOPSY IS DONE AND ONCE RELEASED, THE MACHINE NEEDS TO GET CHECKED/SERVICED BY A BAXTER ENGINEER. ADDITIONAL INFORMATION OBTAINED ON 08 DEC 2010 IS AS FOLLOWS: EQUIPMENT IN USE AT TIME OF INCIDENT: EDWARDS BM25 HEMOFILTER WITH EDWARD LIFESCIENCES HAEMOTRONIC BM25 HEMOFILTER LINES. BAXTER RECEIVED A CALL FROM (B)(6) POLICE ON 08 DEC 10 AND WERE INFORMED THAT THE UNIT WAS AVAILABLE FOR TESTING AT THE POLICE STATION. BAXTER ARRANGED FOR A BAXTER ENGINEER TO VISIT THE POLICE STATION ON 09 DEC 2010. AT THIS TIME, VERBAL CONFIRMATION WAS RECEIVED FROM THE BAXTER ENGINEER THAT THE DEVICE WENT THROUGH THE INITIAL SELF TEST WITHOUT ANY ALARMS OR ISSUES AND A FULL CALIBRATION CHECK WAS PERFORMED AND FOUND TO BE WITHIN SPECIFICATION. A SERVICE HISTORY REVIEW OF THE BM11A (B)(4) AND BM14 (B)(4) (WHICH COMPRISE THE BM25) WAS PERFORMED. BOTH SERVICE VISITS IN 2010 ((B)(6) 2010 AND (B)(6) 2010) WERE COMPLETED AS PER THE SERVICE SCHEDULE AND ON BOTH OCCASIONS, THE DEVICE WAS SERVICED AS PER THE SERVICE MANUAL AND LEFT IN A FULLY FUNCTIONAL AND OPERATIONAL STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOFILTRATION UNIT BM11 + BM14 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI EDWARDS LIFESCIENCES GERMANY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death