NIPRO ELISIO -H HEMODIALYZERRecalls & reported problems across all models

We found 5 models of NIPRO ELISIO -H HEMODIALYZER by Nipro Medical Corporation in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Oct 2, 2018 and Mar 6, 2025 — classified as 5 deaths, 14 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NIPRO ELISIO -H HEMODIALYZER problems

NIPRO ELISIO -H HEMODIALYZER models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-17H

  Dialyzer, high permeability with or without sealed dialysate system
  2 deaths12 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-21H

  Dialyzer, high permeability with or without sealed dialysate system
  9 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-19H

  Dialyzer, high permeability with or without sealed dialysate system
  3 deaths7 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-25H

  Dialyzer, high permeability with or without sealed dialysate system
  6 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-15H

  Dialyzer, high permeability with or without sealed dialysate system
  3 reports

Recent NIPRO ELISIO -H HEMODIALYZER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  1.5 HOURS INTO DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. TREATMENT WAS INTERRUPTED AND PATIENT WAS MOVED TO A DIFFERENT MACHINE/SET-UP. APPROXIMATELY 250ML OF BLOOD LOSS. THE TEST STRIP WE USED WAS POSITIVE AND NO BLOOD WAS VISIBLE IN THE AFFLUENT DIALYSATE. WE HAD NO OTHER BLOOD LEAKS WITH THIS LOT NUMBER. ZOFRAN WAS ADMINISTERED TO THE PATIENT. THERE WERE NO MEDICAL INTERVENTIONS, HOWEVER PATIENT DID REQUIRE DIALYSIS ACCESS REVISION THE FOLLOWING DAY. DIALYSIS SETTINGS: BFR 350, DFR 600

  Patient problems: Insufficient Information

  MAUDE report 21537850 ↗
• MalfunctionMar 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  1.5 HOURS INTO DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. TREATMENT WAS INTERRUPTED AND PATIENT WAS MOVED TO A DIFFERENT MACHINE/SET-UP. APPROXIMATELY 250ML OF BLOOD LOSS. THE TEST STRIP WE USED WAS POSITIVE AND NO BLOOD WAS VISIBLE IN THE AFFLUENT DIALYSATE. WE HAD NO OTHER BLOOD LEAKS WITH THIS LOT NUMBER. ZOFRAN WAS ADMINISTERED TO THE PATIENT. THERE WERE NO MEDICAL INTERVENTIONS, HOWEVER PATIENT DID REQUIRE DIALYSIS ACCESS REVISION THE FOLLOWING DAY. DIALYSIS SETTINGS: BFR 350, DFR 600.

  Patient problems: Insufficient Information

  MAUDE report 21537629 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  15 MINUTES INTO HDF DIALYSIS TREATMENT, STAFF NOTICED BLOODLEAK IN THE DIALYZER. MACHINE DID NOT ALARM FOR ANY ISSUES, ONLY VAM (VENOUS ACCES MONITOR) ALARM WAS NOTED. THE FACILITY TESTED FOR BLOOD LEAK AND RESULTS WERE POSITIVE. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTED. PER FACILITY, PATIENT HAS BEEN USING THE ELISIO-H DIALYZERS FOR THE PAST 4 YEARS. THE PRIMING PROCEDURES WERE ACCORDING TO THE FRESENIUS MACHINE FOR ONLINE PRIMING. DIALYSIS SETTING SWERE HDF POST DILUTION. STILL PENDING ADDITIONAL INFORMATION FROM FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 19106768 ↗
• 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 ↗
• 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 (PATIENT REQUIRED BLOOD TRANSFUSION ON (B)(6) 2021) (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 DOCUMENTE

  Patient problems: Anemia

  MAUDE report 11899052 ↗

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