BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008K HEMODIALYSIS SYSTEM OLC/DIASAFE PLUS W/O HP

    MDR report key: 4764496 · Received May 11, 2015

    Report

    Report Number
    2937457-2015-00857
    Event Type
    Death
    Date Received
    May 11, 2015
    Date of Event
    March 21, 2015
    Report Date
    April 8, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED MEDICAL RECORD REVIEW: BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DEPARTMENT HAS REVIEWED THE MEDICAL RECORDS PROVIDED. THE PATIENT IS A (B)(6) MALE, WITH (END STAGE RENAL DISEASE) ESRD ON HEMODIALYSIS THERAPY. THE PATIENT HAD HEMODIALYSIS THERAPY ON (B)(6) 2015. THE PATIENT BECAME "FIDGETY" AND REQUESTED THE TREATMENT BE TERMINATED EARLY. ON (B)(6) 2015, THE PATIENT HAD HEMODIALYSIS THERAPY WHERE HE WAS ADMINISTERED PAIN AND ANTI-NAUSEA MEDICATION FOR COMPLAINTS OF PAIN. APPROXIMATELY 2 HOURS 45 MINUTES INTO TREATMENT, THE PATIENT BECAME NON-RESPONSIVE. ATTEMPTS AT RESUSCITATION WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. THE PATIENT HAS A DOCUMENTED HISTORY OF MEDICAL NON-COMPLIANCE AND THIS WAS LISTED AS A SECONDARY CAUSE OF DEATH. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT SHOWS A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S HEMODIALYSIS TREATMENT AND THE PATIENT'S DEATH. DEVICE REVIEW: THE USER FACILITY DID NOT REQUEST AN EVALUATION OF THE DEVICE BY THE MANUFACTURER'S REGIONAL EQUIPMENT SPECIALIST. THE CUSTOMER PERFORMED FUNCTION TESTS ON THE 2008K MACHINE AFTER THE EVENT. THE FUNCTION CHECKS PASSED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE BEEN MANUFACTURED PER SPECIFICATIONS. THE USER FACILITY REPORTED THE DEVICE WAS RETURNED TO SERVICE ON 03/30/2015. THE SYSTEM LEVEL REVIEW OF THE 2008K MACHINE AND CONCOMITANT PRODUCTS FOUND NO INDICATION THAT THE PRODUCTS CAUSED OR CONTRIBUTED IN ANY WAY TO THE PATIENT EVENT.

    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. MEDICAL RECORD REVIEW: MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY POST MARKET SURVEILLANCE CLINICAL STAFF. IT WAS NOTED THAT THE MEDICAL RECORDS DID NOT CONTAIN A DEATH CERTIFICATE OR AUTOPSY REPORT FOR REVIEW. BICARBONATE BLOOD LABS ARE NOT REPORTED IN THE MEDICAL RECORDS FOR REVIEW. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT SHOWS AS CAUSAL RELATIONSHIP BETWEEN THE PT'S HEMODIALYSIS TREATMENT AND THE PT'S DEATH. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    THE PT PRESENTED AT THE HOSPITAL ON (B)(6) 2015 WITH CHEST PAIN AND HEADACHE. HE STATED HE DEVELOPED A HEADACHE EARLIER THAT DAY DURING HIS DIALYSIS TREATMENT. HIS CHEST PAIN DEVELOPED ON THE LEFT SIDE AND RADIATED TO HIS LEFT ARM, NECK AND JAW. HE ALSO EXPERIENCED ORTHOPNEA, BLURRY VISION AND LIGHTHEADEDNESS. HIS VITAL SIGNS: BP 237/117, HEART RATE 110, OXYGEN SATURATION 77% ON ROOM AIR AND 90% ON OXYGEN AT 4 LITERS/MIN. THE PT WAS GIVEN INTRAVENOUS ANTI-HYPERTENSIVE MEDICATIONS. THE PT WAS DIAGNOSED WITH HYPERTENSIVE URGENCY AND ADMITTED TO THE HOSPITAL. ON (B)(6) 2015, THE PT STOPPED HIS HEMODIALYSIS TREATMENT. HE HAD BEEN FIDGETY DURING THE DIALYSIS TREATMENT AND BLOOD FLOWS WERE LOWERED. ON (B)(6) 2015, THE PT STARTED HEMODIALYSIS AT 08:14. HIS VITAL SIGNS WERE TEMP. 97.9, PULSE 88, RESPIRATIONS 16, BP 186/100. DURING HIS DIALYSIS TREATMENT, HE HAD RECEIVED ZOFRAN, NORCO AND PHENERGAN. AT 11:00, THIS PT BECAME NON-RESPONSIVE DURING HIS HEMODIALYSIS TREATMENT. HIS HEART RATE WAS IN THE 40S AND HE WAS PLACED ON BIPAP, NARCAN WAS ADMINISTERED WITH NO IMPROVEMENT. EKG SHOWED PEAKED T-WAVES. PULSE WAS LATER LOST AND PT WENT INTO VENTRICULAR FIBRILLATION. CODE BLUE WAS CALLED AND CPR WAS INITIATED APPROX AT 11:19. PT WAS DEFIBRILLATED 4 TIMES. TIME OF DEATH WAS CALLED AT 11:49.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON ADDITIONAL MEDICAL INFORMATION PROVIDED BY THE PATIENT'S NURSE. ON (B)(6) 2015 THE PATIENT'S HEMODIALYSIS TREATMENT ORDERS WERE AS FOLLOWS: DIALYZER F160, DURATION 4.5 HOURS, BLOOD FLOW RATE: AS TOLERATED, DIALYSIS FLOW RATE: 800, DIALYSATE K2, CA2.5, BICARB 32, NA 137. THE PATIENT'S CHRONIC OUT-PATIENT DIALYSIS FACILITY PROVIDED (B)(4) IN LIEU OF THE DEATH CERTIFICATE. THE RECORD WAS RECEIVED AND THE PRIMARY CAUSE OF DEATH WAS LISTED AS CARDIAC ARREST, CAUSE UNKNOWN. SECONDARY CAUSES WERE LISTED AS CARDIOMYOPATHY AND OTHER - CHRONIC MEDICAL NONCOMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306651 2008K HEMODIALYSIS SYSTEM OLC/DIASAFE PLUS W/O HP KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| H| L SENSIPAR| CLONIDIN| OPTIFLUX 160NRE DIALYZER| NATURALYTE| TOPROL| HYRALAZINE