BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008K2 HEMODIALYSIS

    MDR report key: 4076483 · Received August 29, 2014

    Report

    Report Number
    2937457-2014-02449
    Event Type
    Death
    Date Received
    August 29, 2014
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY BIOMED STAFF CALLED FMC TO REQUEST FUNCTIONAL CHECKS OF THE DEVICE, PER POLICY, FOLLOWING AN ADVERSE EVENT. THE DEVICE WAS EVALUATED BY A FMC REG EQUIPMENT SPECIALIST. VERIFICATION OF OPERATIONS WAS COMPLETED AND INCLUDED FUNCTIONAL CHECKS AND RUNNING A SIMULATED TREATMENT. THE MACHINE PASSED ALL VERIFICATIONS. THE CLINICAL INVESTIGATION INDICATES THERE WAS NO ALLEGED DEVICE MALFUNCTION. THE FMC PHARMACOVIGILANCE PHYSICIAN CONCLUDES THE EVENT OF DEATH IS NOT RELATED TO THE DEVICE USED. THE PT WAS BRAIN DEAD AT THE TIME OF RECEIVING HEMODIALYSIS TREATMENT AND HER CO-MORBID STATUS CONTRIBUTED TO HER DEATH. THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MEDICAL CARE AS A REMEDIATION ACTION COMMITTED TO FDA REGARDING ALL POTENTIAL ADVERSE EVENTS RECEIVED BETWEEN 03/21/2011 TO 03/11/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER FACILITY OF THE FMC DEVICE, "..A PT CODED DURING TREATMENT TODAY." THE PT WAS DECLARED BRAIN DEAD FOLLOWING A CEREBRAL VASCULAR ACCIDENT (CVA), BUT WAS STILL UNDERGOING DIALYSIS AT THE REQUEST OF HER FAMILY. EXACT DATE OF THE EVENT IS UNK. POST CVA, THE PT WAS BROUGHT TO THE HOSP WHERE SHE WAS RECEIVING HEMODIALYSIS AT THE ACUTE DIALYSIS UNIT FOR 2 WEEKS PRIOR TO HER DEATH. ON (B)(6) 2011, 20 MINS INTO THE TREATMENT, THE PT CODED AND MET WITH HER DEATH. AT THE TIME OF HER TREATMENT, SHE WAS LETHARGIC, POSTURING, VITAL SIGNS WERE UNSTABLE AND SHE WAS UNRESPONSIVE TO ANY COMMAND OR QUESTION. PRIOR TO TREATMENT INITIATION, THE PT HAD HYPOTENSION AND TACHYCARDIA, INDICATIVE OF CARDIAC INSTABILITY. THE PT WAS GIVEN 500 UNITS OF EPO. ACCORDING TO THE (PT'S) NURSE, THERE WERE NO PROBLEMS WITH THE TREATMENT AND THE DEVICE PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527617 2008K2 HEMODIALYSIS KDI FRESENIUS MEDICAL CARE NORTH AMERICA K2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death