BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 19889324 · Received August 1, 2024

    Report

    Report Number
    3016250252-2024-00003
    Event Type
    Death
    Date Received
    August 1, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 5, 2024
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    UDI-DI
    00383790008815
    PMA / PMN Number
    K182940
    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 06/21/2024 DUE TO LOW OXYGEN SATURATION AND GI ISSUES, DISCHARGED FROM THE HOSPITAL 07/02/202024. 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: 22EW0301. MACHINE PULLED OUT OF SERVICE, DIALYSATE SAMPLES WERE DRAWN. OTHER DEVICES USE: NIPRO BLOOD TUBING SET, CODE: BL+A430/V912, LOT# 23K29 NIPRO ELISIO-H DIALYZER, CODE: DD+ELISIO-17H, LOT# 24C28H

    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 ON (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 BLOOD TUBING SET, CODE: BL+A430/V912, LOT# 23K29. NIPRO ELISIO-H DIALYZER, CODE: DD+ELISIO-17H, LOT# 24C28H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217530 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01 00383790008815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death