NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-17HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00383790007108), received between Sep 11, 2019 and Dec 12, 2024 — classified as 2 deaths, 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE BEGINNING OF TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. BLOOD LEAK CONFIRMED WITH POSITIVE BLOOD LEAK STRIP. PER FACILITY POLICIES AND PROCEDURES, THEY WERE UNABLE TO RETURN THE PATIENT'S BLOOD (APPROXIMATELY 200-250ML OF BLOOD IN EXTRACORPOREAL SYSTEM). PATIENT WAS PLACED ON A NEW EXTRACORPOREAL SYSTEM TO COMPLETE TREATMENT. NO INTERVENTION NECESSARY. NO SAMPLES AVAILABLE, NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20914440 ↗
• MalfunctionDec 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE BEGINNING OF TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. BLOOD LEAK CONFIRMED WITH POSITIVE BLOOD LEAK STRIP. PER FACILITY POLICIES AND PROCEDURES, THEY WERE UNABLE TO RETURN THE PATIENT'S BLOOD (APPROXIMATELY 200-250ML OF BLOOD IN EXTRACORPOREAL SYSTEM). PATIENT WAS PLACED ON A NEW EXTRACORPOREAL SYSTEM TO COMPLETE TREATMENT. NO INTERVENTION NECESSARY. NO SAMPLES AVAILABLE, NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20914244 ↗
• DeathMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 10: 54 AM, WITH 34 MINUTES INTO A 2.5 HRS TREATMENT, PATIENT SAID HE NEEDS TO USE THE RESTROOM DUE TO BOWEL MOVEMENT AND WAS RESTLESS, BP WAS 84/42 MMHG, P=67. STAFF PUT PATIENT ON T POSITION AND STAFF NOTICED AFTER THAT PATIENT HAD A BLANK STARE AND WAS UNRESPONSIVE. NURSE WAS CALLED, BLOOD WAS RETURNED, AND TREATMENT WAS ENDED. NURSE DID A CHEST RUB, GAVE OXYGEN AND 911 WAS CALLED. AT 11:03 AM BLOOD SUGAR WAS 113MG/DL. 11:06 AM - BP WAS 127/66, P 119, BUT RESPIRATORY RATE WAS ONLY 2 AND NURSE WAS GIVING OXYGEN THROUGH AMBU BAG. PARAMEDICS CAME AND PRONOUNCED THE PATIENT DECEASED AT 11:17 AM. FAMILY WAS CONTACTED AND DECIDED NOT TO SEND PATIENT TO THE HOSPITAL. PATIENT HAD PREVIOUSLY SIGNED A DNR ON (B)(6) 2022. PATIENT HAS A HISTORY OF NON-COMPLIANCE, MISSING AND NOT COMPLETING TREATMENTS. PATIENT TREATMENT ORDERS/INFORMATION: TX TIME - 2.5 HRS; BFR - 300; DFR - 500; EDW - (B)(6). PATIENT CAME IN @ (B)(6), GOAL SET AT 600 ML. BP AT START OF TREATMENT - 90/51 MMHG, P= 66. ONLY HEPARIN 2000 UNITS WAS GIVEN. NO NEW MEDICATIONS STARTED. OTHER PRODUCTS USED DURING THE EVENT: NIPRO SDX BLOOD TUBING SET - 20F15; NIPRO AVF TULIP 16G NEEDLE - 21J06B; CITRIC ACID - AC-200 - N1H007; NIPR

  Patient problems: Decreased Respiratory Rate; Loss of consciousness; Low Oxygen Saturation

  MAUDE report 14477874 ↗
• DeathMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 10: 54 AM, WITH 34 MINUTES INTO A 2.5 HRS TREATMENT, PATIENT SAID HE NEEDS TO USE THE RESTROOM DUE TO BOWEL MOVEMENT AND WAS RESTLESS, BP WAS 84/42 MMHG, P=67. STAFF PUT PATIENT ON T POSITION AND STAFF NOTICED AFTER THAT PATIENT HAD A BLANK STARE AND WAS UNRESPONSIVE. NURSE WAS CALLED, BLOOD WAS RETURNED, AND TREATMENT WAS ENDED. NURSE DID A CHEST RUB, GAVE OXYGEN AND 911 WAS CALLED. AT 11:03 AM BLOOD SUGAR WAS 113MG/DL. 11:06 AM - BP WAS 127/66, P 119, BUT RESPIRATORY RATE WAS ONLY 2 AND NURSE WAS GIVING OXYGEN THROUGH AMBU BAG. PARAMEDICS CAME AND PRONOUNCED THE PATIENT DECEASED AT 11:17 AM. FAMILY WAS CONTACTED AND DECIDED NOT TO SEND PATIENT TO THE HOSPITAL. PATIENT HAD PREVIOUSLY SIGNED A DNR ON (B)(6) 2022. PATIENT HAS A HISTORY OF NON-COMPLIANCE, MISSING AND NOT COMPLETING TREATMENTS. PATIENT TREATMENT ORDERS/INFORMATION: TX TIME - 2.5 HRS; BFR - 300; DFR - 500; EDW - (B)(6). PATIENT CAME IN @ (B)(6), GOAL SET AT 600 ML. BP AT START OF TREATMENT - 90/51 MMHG, P= 66. ONLY HEPARIN 2000 UNITS WAS GIVEN. NO NEW MEDICATIONS STARTED. OTHER PRODUCTS USED DURING THE EVENT: NIPRO SDX BLOOD TUBING SET - 20F15; NIPRO AVF TULIP 16G NEEDLE - 21J06B; CITRIC ACID - AC-200 - N1H007; NIPR

  Patient problems: Decreased Respiratory Rate; Loss of consciousness; Low Oxygen Saturation

  MAUDE report 14477252 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  58 MINUTES INTO A TWO-HOUR DIALYSIS TREATMENT THE AFFECTED PATIENT STARTED VOMITING AND SUBSEQUENTLY HAD A WITNESSED GRAND-MAL SEIZURE. THIS LASTED 1-2 MINUTES AND THEN SUBSIDED. THE TREATMENT WAS ENDED WITH A TOTAL OF 489 ML UF(ULTRAFILTRATION). EMS WAS DISPATCHED AND BY THE TIME THEY ARRIVED IN THE FACILITY THE PATIENT WAS FULLY CONSCIOUS AND RECOVERED FROM THE EVENT. THE NURSE NOTED THAT THERE WAS NO CHANGE IN VITAL SIGNS BEFORE THE EVENT, AND NO INDICATION TO HER THAT THERE WAS AN IMPENDING EVENT. THIS PATIENT IS AN ESTABLISHED DIALYSIS PATIENT WITH NO HISTORY OF SEIZURES. PER THE NURSE, AFTER THE EVENT THE PATIENTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED, BUT WITHIN NORMAL RANGE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND CLEARED TO RETURN BACK TO THE NURSING HOME THAT SAME DAY. THE PATIENT RECEIVED DIALYSIS TREATMENTS WEDNESDAY 4/20/2022, THURSDAY 4/21/2022 AND FRIDAY 4/22/2022 WITH NO ADVERSE EVENTS. 4/25/2022: RN SAID PATIENT DIALYZED WITH NO ISSUES. PATIENT HAD HISTORY OF STROKE BUT NO HISTORY OF SEIZURES. PER NURSE, NO MEDICATIONS WERE GIVEN DURING THE TREATMENT WHEN THE EVENT HAPPENED, AND NO NEW MEDICATION WAS STARTED. PATIENT HAS CVC BUT HAD AVF SURGERY 4/11/2022. VITAL S

  Patient problems: Convulsion/Seizure; High Blood Pressure/ Hypertension

  MAUDE report 14472862 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  58 MINUTES INTO A TWO-HOUR DIALYSIS TREATMENT THE AFFECTED PATIENT STARTED VOMITING AND SUBSEQUENTLY HAD A WITNESSED GRAND-MAL SEIZURE. THIS LASTED 1-2 MINUTES AND THEN SUBSIDED. THE TREATMENT WAS ENDED WITH A TOTAL OF 489 ML UF (ULTRAFILTRATION). EMS WAS DISPATCHED AND BY THE TIME THEY ARRIVED IN THE FACILITY THE PATIENT WAS FULLY CONSCIOUS AND RECOVERED FROM THE EVENT. THE NURSE NOTED THAT THERE WAS NO CHANGE IN VITAL SIGNS BEFORE THE EVENT, AND NO INDICATION TO HER THAT THERE WAS AN IMPENDING EVENT. THIS PATIENT IS AN ESTABLISHED DIALYSIS PATIENT WITH NO HISTORY OF SEIZURES. PER THE NURSE, AFTER THE EVENT THE PATIENTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED, BUT WITHIN NORMAL RANGE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND CLEARED TO RETURN BACK TO THE NURSING HOME THAT SAME DAY. THE PATIENT RECEIVED DIALYSIS TREATMENTS WEDNESDAY (B)(6) 2022, THURSDAY (B)(6) 2022 AND FRIDAY (B)(6) 2022 WITH NO ADVERSE EVENTS. (B)(6) 2022: RN SAID PATIENT DIALYZED WITH NO ISSUES. PATIENT HAD HISTORY OF STROKE BUT NO HISTORY OF SEIZURES. PER NURSE, NO MEDICATIONS WERE GIVEN DURING THE TREATMENT WHEN THE EVENT HAPPENED, AND NO NEW MEDICATION WAS STARTED. PATIENT HAS CVC BUT HAD AVF SURGERY (B)(6) 202

  Patient problems: Convulsion/Seizure; High Blood Pressure/ Hypertension

  MAUDE report 14472211 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  58 MINUTES INTO A TWO-HOUR DIALYSIS TREATMENT THE AFFECTED PATIENT STARTED VOMITING AND SUBSEQUENTLY HAD A WITNESSED GRAND-MAL SEIZURE. THIS LASTED 1-2 MINUTES AND THEN SUBSIDED. THE TREATMENT WAS ENDED WITH A TOTAL OF 489 ML UF(ULTRAFILTRATION). EMS WAS DISPATCHED AND BY THE TIME THEY ARRIVED IN THE FACILITY THE PATIENT WAS FULLY CONSCIOUS AND RECOVERED FROM THE EVENT. THE NURSE NOTED THAT THERE WAS NO CHANGE IN VITAL SIGNS BEFORE THE EVENT, AND NO INDICATION TO HER THAT THERE WAS AN IMPENDING EVENT. THIS PATIENT IS AN ESTABLISHED DIALYSIS PATIENT WITH NO HISTORY OF SEIZURES. PER THE NURSE, AFTER THE EVENT THE PATIENTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED, BUT WITHIN NORMAL RANGE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND CLEARED TO RETURN BACK TO THE NURSING HOME THAT SAME DAY. THE PATIENT RECEIVED DIALYSIS TREATMENTS WEDNESDAY (B)(6) 2022, THURSDAY (B)(6) 2022 AND FRIDAY (B)(6) 2022 WITH NO ADVERSE EVENTS. (B)(6) 2022: RN SAID PATIENT DIALYZED WITH NO ISSUES. PATIENT HAD HISTORY OF STROKE BUT NO HISTORY OF SEIZURES. PER NURSE, NO MEDICATIONS WERE GIVEN DURING THE TREATMENT WHEN THE EVENT HAPPENED, AND NO NEW MEDICATION WAS STARTED. PATIENT HAS CVC BUT HAD AVF SURGERY (B)(6) 2022

  Patient problems: Convulsion/Seizure; High Blood Pressure/ Hypertension

  MAUDE report 14469711 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  58 MINUTES INTO A TWO-HOUR DIALYSIS TREATMENT THE AFFECTED PATIENT STARTED VOMITING AND SUBSEQUENTLY HAD A WITNESSED GRAND-MAL SEIZURE. THIS LASTED 1-2 MINUTES AND THEN SUBSIDED. THE TREATMENT WAS ENDED WITH A TOTAL OF 489 ML UF(ULTRAFILTRATION). EMS WAS DISPATCHED AND BY THE TIME THEY ARRIVED IN THE FACILITY THE PATIENT WAS FULLY CONSCIOUS AND RECOVERED FROM THE EVENT. THE NURSE NOTED THAT THERE WAS NO CHANGE IN VITAL SIGNS BEFORE THE EVENT, AND NO INDICATION TO HER THAT THERE WAS AN IMPENDING EVENT. THIS PATIENT IS AN ESTABLISHED DIALYSIS PATIENT WITH NO HISTORY OF SEIZURES. PER THE NURSE, AFTER THE EVENT THE PATIENTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED, BUT WITHIN NORMAL RANGE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND CLEARED TO RETURN BACK TO THE NURSING HOME THAT SAME DAY. THE PATIENT RECEIVED DIALYSIS TREATMENTS WEDNESDAY(B)(6) 2022, THURSDAY (B)(6) 2022 AND FRIDAY (B)(6) 2022 WITH NO ADVERSE EVENTS. (B)(6) 2022: RN SAID PATIENT DIALYZED WITH NO ISSUES. PATIENT HAD HISTORY OF STROKE BUT NO HISTORY OF SEIZURES. PER NURSE, NO MEDICATIONS WERE GIVEN DURING THE TREATMENT WHEN THE EVENT HAPPENED, AND NO NEW MEDICATION WAS STARTED. PATIENT HAS CVC BUT HAD AVF SURGERY (B)(6) 2022.

  Patient problems: Convulsion/Seizure; High Blood Pressure/ Hypertension

  MAUDE report 14469500 ↗
• MalfunctionApr 8, 2020Leak/Splash; Leak/Splash

  WITH 2 HOURS LEFT OF DIALYSIS TREATMENT, STAFF NOTICED THAT BLOOD WAS VISIBLE ON THE ARTERIAL HANSON DIALYSATE LINE. TREATMENT WAS STOPPED AND TERMINATED IMMEDIATELY, BLOOD WAS NOT RETURNED. THE DIALYSIS MACHINE WAS PULLED OUT OF THE HOSPITAL UNIT FLOOR AND NO NEW SET UP WAS STARTED. PATIENT HAD SHORTNESS OF BREATH, BUT STAFF WAS NOT SURE IF THE PATIENT HAD THESE SYMPTOMS PRIOR TO TREATMENT. TREATMENT INFO: TIME = 4 HRS, BFR/DFR = 300/600, HEPARIN = GOT 1900 UNITS DURING TREATMENT (DIDN'T SPECIFY IF IT'S BOLUS/MAINTENANCE), NO OTHER MEDICATIONS DURING TREATMENT, HAS CVC, USING GAMBRO MACHINE, 5TH TREATMENT ON ELISIO. ADDITIONAL INFORMATION RECEIVED 03/30/2020: CAUSE OF PATIENT DEATH WAS NATURAL; PER CORONER. BLOOD CULTURES WERE OBTAINED AND NEGATIVE ON DAY OF EVENT. PATIENT HAD MULTIPLE COMORBIDITIES INCLUDING CHF (CONGESTIVE HEART FAILURE) WITH REDUCED EJECTION FRACTION, AF(ARTERIAL FIBRILLATION) WITH RVR(RAPID VENTRICULAR RATE), CKD(CHRONIC KIDNEY DISEASE), AND OBESITY. HE DID NOT TOLERATE HD DUE PRIMARILY TO HYPOTENSION ON TREATMENT WITH INABILITY TO REMOVE FLUID AND WAS MASSIVELY FLUID OVERLOADED. PATIENT DID NOT WISH TO PURSUE DIALYSIS, AND CHOSE A COMFORT BASED APPROACH AFTER

  Patient problems: Blood Loss; Death

  MAUDE report 9935944 ↗
• MalfunctionApr 8, 2020Adverse Event Without Identified Device or Use Problem

  WITH 2 HOURS LEFT OF DIALYSIS TREATMENT, STAFF NOTICED THAT BLOOD WAS VISIBLE ON THE ARTERIAL HANSON DIALYSATE LINE. TREATMENT WAS STOPPED AND TERMINATED IMMEDIATELY, BLOOD WAS NOT RETURNED. THE DIALYSIS MACHINE WAS PULLED OUT OF THE HOSPITAL UNIT FLOOR AND NO NEW SET UP WAS STARTED. PATIENT HAD SHORTNESS OF BREATH, BUT STAFF WAS NOT SURE IF THE PATIENT HAD THESE SYMPTOMS PRIOR TO TREATMENT. TREATMENT INFO: TIME = 4 HRS. BFR/DFR = 300/600. HEPARIN = GOT 1900 UNITS DURING TREATMENT (DIDN'T SPECIFY IF IT'S BOLUS/MAINTENANCE). NO OTHER MEDICATIONS DURING TREATMENT. HAS CVC. USING GAMBRO MACHINE. 5TH TREATMENT ON ELISIO. ADDITIONAL INFORMATION RECEIVED 03/30/2020: CAUSE OF PATIENT DEATH WAS NATURAL; PER CORONER. BLOOD CULTURES WERE OBTAINED AND NEGATIVE ON DAY OF EVENT. PATIENT HAD MULTIPLE COMORBIDITIES INCLUDING CHF (CONGESTIVE HEART FAILURE) WITH REDUCED EJECTION FRACTION, AF(ARTERIAL FIBRILLATION) WITH RVR(RAPID VENTRICULAR RATE), CKD(CHRONIC KIDNEY DISEASE), AND OBESITY. HE DID NOT TOLERATE HD DUE PRIMARILY TO HYPOTENSION ON TREATMENT WITH INABILITY TO REMOVE FLUID AND WAS MASSIVELY FLUID OVERLOADED. PATIENT DID NOT WISH TO PURSUE DIALYSIS, AND CHOSE A COMFORT BASED APPROACH AFTER

  Patient problems: Death; Dyspnea; Low Blood Pressure/ Hypotension

  MAUDE report 9935741 ↗
• MalfunctionSep 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  15 MINUTES INTO A 3.5 HRS DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. BLOOD LEAK WAS CONFIRMED WITH A POSITIVE BLOOD LEAK TEST STRIP. PATIENT'S BLOOD WAS NOT RETURNED, LOST APPROXIMATELY 150ML OF BLOOD. PATIENT WAS IN GOOD CONDITION AND DID NOT REQUIRE ANY ADDITIONAL MEDICATIONS, A NEW MACHINE WAS SET UP. PATIENT WAS ABLE TO COMPLETE THEIR DIALYSIS TREATMENT. PRESENT HEMOGLOBIN WAS 11.3. DIALYSIS CONDITIONS: PRIMED WITH BFR OF 100ML/HR WITH 300ML VOLUME. TREATMENT TIME IS 3.5 HRS, 400 BFR, 600 DFR. MEDICATIONS: ZEMPLAR 6MCG. VASCULAR ACCESS: RIGHT (AVF) ARTERIAL VENOUS FISTULA. OTHER DEVICES USED: FRESENIUS DIALYSIS MACHINE, STREAMLINE BLOODLINES, MASTERGUARD.

  Patient problems: Blood Loss

  MAUDE report 8994592 ↗
• InjurySep 11, 2019Fluid/Blood Leak

  15 MINUTES INTO A 3.5HRS DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. BLOOD LEAK WAS CONFIRMED WITH A POSITIVE BLOOD LEAK TEST STRIP. PATIENT'S BLOOD WAS NOT RETURNED, LOST APPROXIMATELY 150ML OF BLOOD. PATIENT WAS IN GOOD CONDITION AND DID NOT REQUIRE ANY ADDITIONAL MEDICATIONS, A NEW MACHINE WAS SET UP. PATIENT WAS ABLE TO COMPLETE THEIR DIALYSIS TREATMENT. PRESENT HEMOGLOBIN WAS 11.3. DIALYSIS CONDITIONS: PRIMED WITH BFR OF 100ML/HR WITH 300ML VOLUME. TREATMENT TIME IS 3.5HRS, 400 BFR, 600 DFR. MEDICATIONS: ZEMPLAR 6MCG. VASCULAR ACCESS: RIGHT (AVF) ARTERIAL VENOUS FISTULA. OTHER DEVICES USED: FRESENIUS DIALYSIS MACHINE, STREAMLINE BLOODLINES, MASTERGUARD.

  Patient problems: Blood Loss

  MAUDE report 8993747 ↗