BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 19337295 · Received May 16, 2024

    Report

    Report Number
    9610987-2024-00003
    Event Type
    Death
    Date Received
    May 16, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 16, 2024
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    UDI-DI
    00383790007115
    PMA / PMN Number
    K131935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LOT NUMBER WAS UNKNOWN, THE INVESTIGATION WAS PERFORMED ON REPRESENTATIVE LOT NUMBERS.

    Description of Event or Problem · 0

    3 HOURS AND 46 MINUTES INTO DIALYSIS TREATMENT PATIENT HAD A CARDIAC EPISODE. FACILITY STATED THAT THEY NOTED THE PATIENT TO HAVE ARRIVED WITH HYPERTENSION PRIOR TO TREATMENT. BLOOD PRESSURE (BP) AT 05:18AM 211/100 HEART RATE (HR) 82, BP AT 05:40AM 220/86 HR 78. TREATMENT INITIATED AT 05:50AM (BP) AT 196/110 (HR) 80. ULTRAFILTRATION (UFR) REDUCED TO 0.1 AT 9:34AM WITH BP 178/97 6 MINUTES PRIOR AND BP 183/89 8 MINUTES POST. MACHINE ALARMED WITH ALL BLOOD PRESSURE READINGS OUT OF PARAMETERS. TREATMENT INTERRUPTED AT 9:43AM, REINFUSION STARTED WITH A TOTAL REINFUSION VOLUME OF 300ML. AT 9:57AM BP 155/147 HR 168, 9:59AM BP 203/167 HR 60, 10:00AM BP 126/82 HR 77, 10:02AM BP 126/28 HR 96. DIALYSATE FLOW RATE (DFR): 700. BLOOD FLOW RATE (BFR): 400, THEN LOWERED TO 375, THEN AGAIN TO 350 DURING TREATMENT UF GOAL 3.5. OTHER DEVICES USED: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM, 510K: K182940, SERIAL# (B)(6). NIPRO BLOOD TUBING SET W/TP, CODE: BL+A430/V912, LOT UNKNOWN. FACILITY DID NOT RETAIN THE LOT NUMBERS USED FOR THE DIALYZER OR BLOODLINE. ACTUAL SAMPLES WERE DISCARDED BY THE FACILITY. PER FACILITY PATIENT DID NOT HAVE ANY RECENT HOSPITALIZATION AND NO CAUSE OF DEATH WAS PROVIDED. MULTIPLE ATTEMPTS MADE TO OBTAIN ADDITIONAL INFORMATION, WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440096 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-17H UNKNOWN 00383790007115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| O