FDA Adverse Event Death Summary report: N

NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

MDR report key: 19889168 · Received August 1, 2024

Report

Report Number
1056186-2024-00013
Event Type
Death
Date Received
August 1, 2024
Date of Event
July 3, 2024
Report Date
August 1, 2024
Manufacturer
SHIBUYA (SBY)
Product Code
KDI
Adverse Event
Yes
Report Source
Distributor 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 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
885978 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

Patients

Seq Age Sex Outcome Treatment
1 NA Female Death