BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 4861417 · Received June 22, 2015

    Report

    Report Number
    2937457-2015-01205
    Event Type
    Death
    Date Received
    June 22, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 22, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. PRODUCT LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DEPT HAS REQUESTED THE PT'S MEDICAL RECORDS BUT THEY HAVE NOT YET BEEN REC'D. THE PLANT INVESTIGATION IS PENDING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATIONS.

    Description of Event or Problem · 1

    A CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) PT'S WIFE CALLED TECHNICAL SUPPORT REQUESTING THE CYCLER AND SUPPLIES BE PICKED UP AS THE PT HAD EXPIRED. SHE STATED THAT THE CYCLER DID NOT CAUSE OR CONTRIBUTE TO THE DEATH AND THE PT WAS NOT CONNECTED AT THE TIME OF THE EVENT. UPON F/U WITH THE PT'S PD NURSE, SHE STATED THAT THE PT UNDERWENT A WOUND DEBRIDEMENT ON (B)(6) 2015 A FOLLOWING THE PROCEDURE BEGAN TO SPIT UP BLOOD. THE PHYSICIAN BELIEVED THE PT HAD BIT HIS TONGUE DURING THE PROCEDURE. THE FOLLOWING MORNING ((B)(6) 2015), THE PT HAD DARK, TARRY STOOLS, BECAME WAS GIVEN HYPOTENSIVE AND HAD A DECREASED HEMOGLOBIN AND HEMATOCRIT. THE PT WAS GIVEN FOUR UNITS OF PACKED RED BLOOD CELLS, LEVOPHED AND STARTED ON A PROTONIX DRIP. HE WAS THEN TRANSFERRED TO DELTA REGIONAL ICU WHERE HE SUBSEQUENTLY EXPIRED A FEW DAYS LATER DUE TO A SEVERE GI BLEED. THE PDRN CONFIRMED THAT THERE WERE NO COMPLICATIONS AT ANY POINT DURING THE PT'S PD TREATMENTS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE GI BLEED. THE ISSUE WAS SOLELY DUE TO THE PT'S CO-MORBIDITIES AND POOR HEALTH. THERE ARE NO ALLEGATIONS OF ANY DEVICE OR PROD MALFUNCTION/FAILURE. PT MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403648 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death FRESENIUS PD SOLUTION