NIPRO Cellentia™-H Hemodialyzer Cellentia™-21HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00383790004411), received between Aug 14, 2019 and Dec 22, 2023 — classified as 4 injuries, 2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT ATTENDED REGULARLY SCHEDULED IN-CENTER DIALYSIS TREATMENT. PRE VITAL SIGNS BP-149/82, PULSE-101, RESPIRATION-21, TEMPERATURE - 97.8. AT APPROX 0954 DIALYSIS WAS INITIATED WITH A USE OF TREATMENT ENDED, PATIENT GIVEN DIPHENHYDRAMINE 50 MG IVP(INTRAVENOUS PUSH). PATIENT DEVELOPED SHORTNESS OF BREATH, SLURRED SPEECH AND RIGHT FACIAL DROOP. 911 CALLED, PATIENT TRANSPORTED TO HOSPITAL VIA EMS(EMERGENCY MEDICAL SERVICES) AND LATER RELEASED. PATIENT RETURNED TO FACILITY (B)(6) 2023, TREATED ON OPTIFLUX 180NR DIALYZER WITHOUT INCIDENT. NIPRO CELLENTIA 21 ADDED AS ALLERGY.

  Patient problems: Dysphasia; Dyspnea

  MAUDE report 18389304 ↗
• InjuryDec 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT ATTENDED REGULARLY SCHEDULED IN-CENTER DIALYSIS TREATMENT. PRE VITAL SIGNS BP-149/82, PULSE-101, RESPIRATION-21, TEMPERATURE - 97.8. AT APPROX 0954 DIALYSIS WAS INITIATED WITH A USE OF TREATMENT ENDED, PATIENT GIVEN DIPHENHYDRAMINE 50 MG IVP(INTRAVENOUS PUSH). PATIENT DEVELOPED SHORTNESS OF BREATH, SLURRED SPEECH AND RIGHT FACIAL DROOP. 911 CALLED, PATIENT TRANSPORTED TO HOSPITAL VIA EMS(EMERGENCY MEDICAL SERVICES) AND LATER RELEASED. PATIENT RETURNED TO FACILITY (B)(6) 2023, TREATED ON OPTIFLUX 180NR DIALYZER WITHOUT INCIDENT. NIPRO CELLENTIA 21 ADDED AS ALLERGY.

  Patient problems: Dysphasia; Dyspnea

  MAUDE report 18388822 ↗
• InjuryMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  1 PATIENT / 2 OCCURRENCES: WHERE THE STAFF HAVE NOTICED MASSIVE AIR BUBBLES IN THE DIALYZER, STAFF DID WHATEVER THEY COULD BUT WERE NOT ABLE TO CLEAR THE BUBBLES AND HAD TO WASTE THE PATIENT'S BLOOD. ADDITIONAL INFORMATION RECEIVED 03/02/2021: PRIMING CONDITIONS - THEY PRIME WITH A BFR OF 100 AND FLUSHED THE DIALYZER WITH AT LEAST A L OF SALINE. DIALYSIS CONDITIONS: BFR 400, DFR: 800, TREATMENT TIME 4 HRS AND NO HEPARIN BRAND/MANUFACTURER NAME & MODELS OF DEVICES USED TOGETHER WITH DIALYZER: GAMBRO MACHINE AND LINES. HOW MUCH BLOOD DID THE PATIENT LOST DUE TO CHANGING THE DIALYZER - 300 ML WAS ANY MEDICAL ACTIONS TAKEN- NONE AS THEIR HGB (AS CLAIMED WHEN THEY RECHECKED) WAS STABLE. WHERE DID THE BUBBLES GENERATE: MIDDLE TO TOP PORTION OF THE DIALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558902 ↗
• MalfunctionMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  1 PATIENT / 2 OCCURRENCES - WHERE THE STAFF HAVE NOTICED MASSIVE AIR BUBBLES IN THE DIALYZER, STAFF DID WHATEVER THEY COULD BUT WERE NOT ABLE TO CLEAR THE BUBBLES AND HAD TO WASTE THE PATIENT'S BLOOD. ADDITIONAL INFORMATION RECEIVED 03/02/2021: 1. PRIMING CONDITIONS - THEY PRIME WITH A BFR OF 100 AND FLUSHED THE DIALYZER WITH AT LEAST A L OF SALINE. 2. DIALYSIS CONDITIONS - BFR 400, DFR - 800, TREATMENT TIME 4 HRS AND NO HEPARIN. 3. BRAND/MANUFACTURER NAME & MODELS OF DEVICES USED TOGETHER WITH DIALYZER - GAMBRO MACHINE AND LINES. 4. HOW MUCH BLOOD DID THE PATIENT LOST DUE TO CHANGING THE DIALYZER - 300 ML. 5. WAS ANY MEDICAL ACTIONS TAKEN- NONE AS THEIR HGB (AS CLAIMED WHEN THEY RECHECKED) WAS STABLE. 6. WHERE DID THE BUBBLES GENERATE - MIDDLE TO TOP PORTION OF THE DIALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558860 ↗
• MalfunctionAug 14, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2019, WITH 1HR AND 20 MINUTES LEFT INTO A 4.25HR TREATMENT, THE SYSTEM CLOTTED AND THE STAFF WAS UNABLE TO RETURN THE PATIENT'S BLOOD. THE CLINIC SET UP A NEW SYSTEM AND PATIENT WAS ABLE TO COMPLETE THE REMAINING 1HR AND 20 MINUTES. PATIENT USED TO RECEIVE HEPARIN BUT WAS STOPPED DUE TO VAGINAL BLEEDING. STAFF DID NOT RECORD THE LOT NUMBER FOR THE DIALYZER USED. CLINIC CHECKED THE PATIENT'S HEMOGLOBIN LEVELS AND THEY WERE 9.2G/DL. (DIALYZER WAS DISPOSED) PATIENT HAS A CVC(DIALYSIS CATHETER), BFR IS 400, DFR IS 800. ON (B)(6): 2ND INCIDENT, SAME PATIENT, WITH 1HR AND 30 MINUTES LEFT INTO A 4.25HR TREATMENT, MACHINE ALARMED FOR HIGH VENOUS PRESSURE, CLOTS WERE NOTED ON THE BLOODLINES AND THE DIALYZER, BUT THE STAFF WAS ABLE TO RETURN THE PATIENT'S BLOOD. PATIENT RECEIVED 2000 UNITS OF BOLUS HEPARIN, CLINIC IS GIVING THE PATIENT 100ML OF HEPARIN FLUSHES EVERY HOUR, AND WILL DO CONTINUOUS FLUSHES OF 300ML/HR WITH HER NEXT SCHEDULED TREATMENT. HEMOGLOBIN LEVELS WERE CHECKED AND THE RESULTS WERE 9 G/DL. PATIENT IS NOW ON MAX DOES OF ARANESP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8895285 ↗
• InjuryAug 14, 2019Device Alarm System; Insufficient Flow or Under Infusion; Obstruction of Flow

  ON (B)(6) 2019, WITH 1 HR AND 20 MINUTES LEFT INTO A 4.25 HR TREATMENT, THE SYSTEM CLOTTED AND THE STAFF WAS UNABLE TO RETURN THE PATIENT'S BLOOD. THE CLINIC SET UP A NEW SYSTEM AND PATIENT WAS ABLE TO COMPLETE THE REMAINING 1 HR AND 20 MINUTES. PATIENT USED TO RECEIVE HEPARIN BUT WAS STOPPED DUE TO VAGINAL BLEEDING. STAFF DID NOT RECORD THE LOT NUMBER FOR THE DIALYZER USED. CLINIC CHECKED THE PATIENT'S HEMOGLOBIN LEVELS AND THEY WERE 9.2 G/DL. (DIALYZER WAS DISPOSED). PATIENT HAS A CVC(DIALYSIS CATHETER), BFR IS 400, DFR IS 800. ON (B)(6): 2ND INCIDENT, SAME PATIENT, WITH 1 HR AND 30 MINUTES LEFT INTO A 4.25 HR TREATMENT, MACHINE ALARMED FOR HIGH VENOUS PRESSURE, CLOTS WERE NOTED ON THE BLOODLINES AND THE DIALYZER, BUT THE STAFF WAS ABLE TO RETURN THE PATIENT'S BLOOD. PATIENT RECEIVED 2000 UNITS OF BOLUS HEPARIN, CLINIC IS GIVING THE PATIENT 100 ML OF HEPARIN FLUSHES EVERY HOUR, AND WILL DO CONTINUOUS FLUSHES OF 300 ML/HR WITH HER NEXT SCHEDULED TREATMENT. HEMOGLOBIN LEVELS WERE CHECKED AND THE RESULTS WERE 9 G/DL. PATIENT IS NOW ON MAX DOES OF ARANESP.

  Patient problems: Blood Loss

  MAUDE report 8895172 ↗