BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER CASSETTE

    MDR report key: 5077751 · Received September 11, 2015

    Report

    Report Number
    8030665-2015-00414
    Event Type
    Death
    Date Received
    September 11, 2015
    Date of Event
    August 8, 2015
    Report Date
    August 13, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE 36 PAGES OF MEDICAL RECORDS INFO IT APPEARS THAT ON (B)(6) 2015, THIS (B)(6) MALE PATIENT EXPIRED. ACCORDING TO THE END STAGE RENAL DISEASE (ESRD) DEATH NOTIFICATION, THE CAUSE OF THE PT'S DEATH WAS CARDIAC ARREST OF UNK CAUSE. THE ESRD DEATH NOTIFICATION DOES NOT MENTION A SECONDARY CAUSE OF DEATH. MEDICAL RECORDS DO NOT CONTAIN A DEATH CERTIFICATE OR AUTOPSY REPORTS FOR REVIEW. DIALYSIS FLOW RECORDS REVEAL THAT THE PT HAS NO INCREASE IN INTRAPERITONEAL VOLUME (IIPV). DIALYSIS FLOW RECORDS REVEAL ANY ADVERSE EVENT OCCURRED FROM (B)(6) 2015. ACCORDING TO THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), THE PT EXPIRED DURING TREATMENT WHILE CONNECTED TO THE CYCLER. MEDICAL RECORDS DO NOT CONFIRM PATIENT WAS RECEIVING HEMODIALYSIS AT THE TIME OF DEATH. PDRN DID NOT HAVE ANY INFO AS TO SIGNS/SYMPTOMS OF THE PT'S CONDITION DURING THE EVENT. MEDICAL RECORDS DO NOT CONTAIN ANY PROGRESS NOTES, DIALYSIS TREATMENT SHEETS, LAB RESULTS OR MEDICATION RECORDS FROM THE DATE OF DEATH FOR REVIEW. MEDICAL RECORDS DO NOT REVEAL ANY MEDICAL INTERVENTION OCCURRED ON DATE OF DEATH. BICARBONATE LEVEL ON (B)(6) 2015 WAS NORMAL. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORDS THAT INDICATES A CAUSAL RELATIONSHIP BETWEEN THE PT'S LIBERTY CYCLER AND CONCOMITANT PRODUCTS AND THE PT'S DEATH. 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 PRODUCT 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 SIX LOT NUMBER SHIPPED TO THE CUSTOMER DURING THE 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 DOCUMENT PRODUCT INVESTIGATION, THERE WAS NO INDICATION THAT THE FRESENIUS PRODUCT CAUSED, CONTRIBUTED TO OR WAS A FACTOR IN THE REPORTED EVENT.

    Description of Event or Problem · 1

    A (B)(6) MALE PERITONEAL DIALYSIS PATIENT EXPIRED AT HOME ON (B)(6) 2015. THE CAUSE OF DEATH LISTED AS CARDIAC ARREST, UNK CAUSE. ACCORDING TO THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), THE PT EXPIRED DURING TREATMENT WHILE CONNECTED TO THE CYCLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603132 LIBERTY CYCLER CASSETTE FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death