NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-19HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00383790007115), received between May 22, 2020 and Aug 1, 2024 — classified as 3 deaths, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathAug 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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

  Patient problems: Anaphylactic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 19889716 ↗
• DeathMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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

  Patient problems: Cardiac Arrest; High Blood Pressure/ Hypertension

  MAUDE report 19337295 ↗
• DeathMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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

  Patient problems: Cardiac Arrest; High Blood Pressure/ Hypertension

  MAUDE report 19337187 ↗
• MalfunctionMay 27, 2021Obstruction of Flow; Obstruction of Flow

  CLINIC STATED THAT THEY HAVE EXPERIENCED AN INCREASE IN CLOTTED DIALYZERS SINCE SWITCHING FROM OPTIFLUX DIALYZERS TO ELISIO DIALYZERS. TREATMENTS ARE INTERRUPTED, AND MOST ARE UNABLE TO RETURN THE PATIENT'S BLOOD.THE CLOTTING IS NOT PATIENT, DIALYZER SIZE, OR USER SPECIFIC. 3 TOTAL INCIDENTS: (B)(6) 2021 - 1 INCIDENT (B)(6) 2021 - 1 INCIDENT (B)(6) 2021 - 1 INCIDENT CLINICAL SPECIALIST CONTACTED THE FACILITY AND OFFERED IN-PERSON PRODUCT TRAINING FOR MAY 3, 4, AND 5TH 2021. CLINIC WAS ADVISED TO FOLLOW IFU FOR PROPER PRIMING INSTRUCTIONS, BECAUSE THE STAFF WAS FOLLOWING CLINIC PROTOCOLS AND NOT THE PRODUCT IFU. AFTER OUR CLINICAL SPECIALIST VISITED THE CLINIC AND OBSERVED THE STAFF DURING PRIMING AND RECIRCULATING PROCESS, IT WAS IDENTIFIED THAT THE CLINIC WAS RECIRCULATING WITH 100ML INSTEAD OF 200ML AS INSTRUCTED IN THE IFU. ARTERIAL CHAMBERS WERE ALSO OBSERVED NOT BE BE 75% FULL IN SOME CASES. DURING HER VISIT TO THE CLINIC, THE NURSE MANAGER ADVISED THAT A PATIENT REQUIRED A BLOOD TRANSFUSION 2 DAYS AFTER TREATMENT WAS INTERRUPTED AND THE PATIENT'S BLOOD COULD NOT BE RETURNED DUE TO THE CLOTTED DIALYZER. ALL DATA WAS DOCUMENTED AND AN EMAIL WITH HER FINDINGS WAS SENT TO THE NUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898991 ↗
• MalfunctionMay 27, 2021Obstruction of Flow; Obstruction of Flow

  CLINIC STATED THAT THEY HAVE EXPERIENCED AN INCREASE IN CLOTTED DIALYZERS SINCE SWITCHING FROM OPTIFLUX DIALYZERS TO ELISIO DIALYZERS. TREATMENTS ARE INTERRUPTED, AND MOST ARE UNABLE TO RETURN THE PATIENT'S BLOOD. THE CLOTTING IS NOT PATIENT, DIALYZER SIZE, OR USER SPECIFIC. 3 TOTAL INCIDENTS: (B)(6) 2021: 1 INCIDENT; (B)(6) 2021: 1 INCIDENT; (B)(6) 2021: 1 INCIDENT. CLINICAL SPECIALIST CONTACTED THE FACILITY AND OFFERED IN-PERSON PRODUCT TRAINING FOR (B)(6) 2021. CLINIC WAS ADVISED TO FOLLOW IFU FOR PROPER PRIMING INSTRUCTIONS, BECAUSE THE STAFF WAS FOLLOWING CLINIC PROTOCOLS AND NOT THE PRODUCT IFU. AFTER OUR CLINICAL SPECIALIST VISITED THE CLINIC AND OBSERVED THE STAFF DURING PRIMING AND RECIRCULATING PROCESS, IT WAS IDENTIFIED THAT THE CLINIC WAS RECIRCULATING WITH 100ML INSTEAD OF 200ML AS INSTRUCTED IN THE IFU. ARTERIAL CHAMBERS WERE ALSO OBSERVED NOT BE 75% FULL IN SOME CASES. DURING HER VISIT TO THE CLINIC, THE NURSE MANAGER ADVISED THAT A PATIENT REQUIRED A BLOOD TRANSFUSION 2 DAYS AFTER TREATMENT WAS INTERRUPTED AND THE PATIENT'S BLOOD COULD NOT BE RETURNED DUE TO THE CLOTTED DIALYZER. ALL DATA WAS DOCUMENTED AND AN EMAIL WITH HER FINDINGS WAS SENT TO THE NURSE MANAGER, P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898967 ↗
• MalfunctionMay 22, 2020Complete Blockage; Fluid/Blood Leak

  CLINIC STAFF NOTICED A DIALYZER BLOOD LEAK. AT THE START OF TREATMENT, CIRCUIT FILLED WITH BLOOD TO JUST PRIOR TO VENOUS CHAMBER, HAD HIGH PRESSURE ALARMS AS ONE NEEDLE CLOTTED. PLACED IN CIRCULATION WHILE NEEDLE PULLED, HEMOSTASIS ACHIEVED. ONCE RECANNULATED, MACHINE TAKEN OUT OF CIRCULATION AND TREATMENT STARTED (IN CIRCULATION ~10MINUTES) BLOOD LEAK ALARM WITHIN SECONDS OF RESTARTING TREATMENT. PATIENT WAS SET UP ON ALTERNATE MACHINE AND COMPLETED TREATMENT. PATIENT WILL BE GIVEN PROPHYLACTIC ANTIBIOTICS. OTHER DEVICES USED: FRESENIUS 5008, LEFT BC AVF, BLOODLINE - COMPATIBLE W/FRESENIUS 5008 DOUBLE NEEDLE, #15G WINGEATER (JMS) NEEDLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10083958 ↗
• MalfunctionMay 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CLINIC STAFF NOTICED A DIALYZER BLOOD LEAK. AT THE START OF TREATMENT, CIRCUIT FILLED WITH BLOOD TO JUST PRIOR TO VENOUS CHAMBER, HAD HIGH PRESSURE ALARMS AS ONE NEEDLE CLOTTED. PLACED IN CIRCULATION WHILE NEEDLE PULLED, HEMOSTASIS ACHIEVED. ONCE RECANNULATED, MACHINE TAKEN OUT OF CIRCULATION AND TREATMENT STARTED (IN CIRCULATION ~10MINUTES) BLOOD LEAK ALARM WITHIN SECONDS OF RESTARTING TREATMENT. PATIENT WAS SET UP ON ALTERNATE MACHINE AND COMPLETED TREATMENT. PATIENT WILL BE GIVEN PROPHYLACTIC ANTIBIOTICS. OTHER DEVICES USED: FRESENIUS 5008, LEFT BC AVF, BLOODLINE - COMPATIBLE W/FRESENIUS 5008 DOUBLE NEEDLE, #15G WINGEATER (JMS) NEEDLES.

  Patient problems: Blood Loss

  MAUDE report 10083905 ↗