BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4764495 · Received May 11, 2015

    Report

    Report Number
    3005162618-2015-00029
    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
    KPO
    PMA / PMN Number
    K981043
    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 TR TREATMENT BE TERMINATED EARLY. ON (B)(6) 2015, THE PATIENT HAD HEMODIALYSIS THERAPY WHERE HE WAS ADMINISTERED PAIN AND ANTI-NAUSEA MEDICATION. APPROXIMATELY 2 HOURS AND 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 DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE MANUFACTURER WITH THE LOT NUMBER OF THE NATURALYTE 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 (B)(4) LOT NUMBERS SHIPPED TO THE CUSTOMER DURING THAT TIME PERIOD. THE BATCH PRODUCTION RECORDS FOR THESE LOTS WERE REVIEWED INCLUDING PACKAGING AND RAW MATERIALS. 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 NATURALYTE CAUSED, CONTRIBUTED TO OR WAS A FACTOR IN THE REPORTED EVENT. 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 (B)(6) 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 THE ESRD DEATH NOTIFICATION (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. PT PRESENTED TO THE HOSPITAL ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306120 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| H| L TOPROL| CLONIDIN| OPTIFLUX DIALYZER| SENSIPAR| COMBISET BLOODLINES| HYRALAZINE