BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 19889716 · Received August 1, 2024

    Report

    Report Number
    9610987-2024-00005
    Event Type
    Death
    Date Received
    August 1, 2024
    Date of Event
    July 3, 2024
    Report Date
    August 23, 2024
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    UDI-DI
    00383790007115
    PMA / PMN Number
    K131935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 DUE TO LOW OXYGEN SATURATION AND GI ISSUES, DISCHARGED FROM THE HOSPITAL (B)(6) 2024. IT WAS HER FIRST TREATMENT IN THE CLINIC POST HOSPITALIZATION. TREATMENT STARTED 7:07AM WITH A BLOOD PRESSURE (BP) OF 110/49 AND IT STARTED DROPPING. 7:30 - BP 93/43 MM/HG: 8:00 - BP 95/52 MM/HG AND 9 AM - BP WAS 99/38 MM/HG AND THEY STOPPED THE ULTRAFILTRATION (UF). PATIENT STARTED VOMITING AND PASSED OUT, CPR WAS PERFORMED, FLUIDS WERE GIVEN AND PARAMEDICS WERE CALLED. THEY TRIED ENDING THE TREATMENT BUT WERE UNABLE TO UNTIL AFTER PATIENT WAS PRONOUNCED DEAD @ 10:24 AM. DIALYZER/BLOODLINES WERE SAVED. STAFF STATED THAT THERE WERE NO ALARMS TRIGGERED BEFORE OR DURING THE EVENT, EXCEPT FOR TREATMENT RELATED ALARMS PRIOR TO EVENT. CAUSE OF DEATH IS STILL UNKNOWN. THERE WERE NO ISSUES REPORTED WITH ANY OF THE NIPRO DEVICES USED. TREATMENT TIME - 3.5 HRS; BLOOD FLOW RATE (BFR) - 250; DIALYSATE FLOW RATE (DFR) - 600; A/B - 3K, 2.5; BICARB - 35, TEMP - 35.5; NA - 138; ACCESS: CVC; UF GOAL - 4L; UF REMOVED - 1.5 L; ESTIMATED DRY WEIGHT (EDW) - 74 KG; PRE WEIGHT - 77.5 KG. MEDICATIONS GIVEN; MIRCERA - 60 MCG; VENOFER - 50 MG. COMORBIDS: CANCER, CHRONIC OBSTRUCTION PULMONARY DISEASE (COPD). MACHINE S/N: (B)(6). MACHINE PULLED OUT OF SERVICE; DIALYSATE SAMPLES WERE DRAWN. OTHER DEVICES USE: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM, CODE: MC+SDX01, SERIAL# (B)(6). NIPRO BLOOD TUBING SET W/TP, CODE: BL+A430/V912, LOT# 23K29.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 DUE TO LOW OXYGEN SATURATION AND GI ISSUES, DISCHARGED FROM THE HOSPITAL (B)(6) 2024. IT WAS HER FIRST TREATMENT IN THE CLINIC POST HOSPITALIZATION. TREATMENT STARTED 7:07AM WITH A BLOOD PRESSURE (BP) OF 110/49 AND IT STARTED DROPPING. 7:30 - BP 93/43 MM/HG: 8:00 - BP 95/52 MM/HG AND 9 AM - BP WAS 99/38 MM/HG AND THEY STOPPED THE ULTRAFILTRATION (UF). PATIENT STARTED VOMITING AND PASSED OUT, CPR WAS PERFORMED, FLUIDS WERE GIVEN AND PARAMEDICS WERE CALLED. THEY TRIED ENDING THE TREATMENT BUT WERE UNABLE TO UNTIL AFTER PATIENT WAS PRONOUNCED DEAD @ 10:24 AM. DIALYZER/BLOODLINES WERE SAVED. STAFF STATED THAT THERE WERE NO ALARMS TRIGGERED BEFORE OR DURING THE EVENT, EXCEPT FOR TREATMENT RELATED ALARMS PRIOR TO EVENT. CAUSE OF DEATH IS STILL UNKNOWN. THERE WERE NO ISSUES REPORTED WITH ANY OF THE NIPRO DEVICES USED. TREATMENT TIME - 3.5 HRS; BLOOD FLOW RATE (BFR) - 250; DIALYSATE FLOW RATE (DFR) - 600; A/B - 3K, 2.5; BICARB - 35, TEMP - 35.5; NA - 138; ACCESS: CVC; UF GOAL - 4L; UF REMOVED - 1.5 L; ESTIMATED DRY WEIGHT (EDW) - 74 KG; PRE WEIGHT - 77.5 KG. MEDICATIONS GIVEN; MIRCERA - 60 MCG; VENOFER - 50 MG COMORBIDS: CANCER, CHRONIC OBSTRUCTION PULMONARY DISEASE (COPD) MACHINE S/N: (B)(6). MACHINE PULLED OUT OF SERVICE; DIALYSATE SAMPLES WERE DRAWN. OTHER DEVICES USE: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM, CODE: MC+SDX01, SERIAL#(B)(6) NIPRO BLOOD TUBING SET W/TP, CODE: BL+A430/V912, LOT# 23K29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958606 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-17H 24C28H 00383790007115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death