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NIPRO Cellentia™-H Hemodialyzer Cellentia™-19HRecalls & reported problems

Nipro Medical Corporation · CELLULOSE TRIACETATE HEMODIALYZER 1.9m² / Max.TMP 66kPa (500mmHg) · Class 2

All models of NIPRO Cellentia-H Hemodialyzer (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383790004404), received between Mar 23, 2021 and Mar 23, 2021 — classified as 1 injury, 1 malfunction.

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

Device problems

  • Fluid/Blood Leak2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

    1 PATIENT/ 3 OCCURRENCES WITH THE SAME LOT # REPORTED. PATIENT LOST BLOOD WITH THE 1ST OCCURRENCE. THE 2ND AND 3RD OCCURRENCE OCCURRED PRIOR TO INITIATING TREATMENT, THE MACHINE KEPT ALARMING FOR AIR. ON THE 3RD OCCURRENCE STAFF CHANGED THE DIALYZER WITH A DIFFERENT LOT # AND TREATMENT WAS COMPLETED WITHOUT COMPLICATIONS. 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 11558920 ↗
  • MalfunctionMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

    1 PATIENT/ 3 OCCURRENCES WITH THE SAME LOT # REPORTED. PATIENT LOST BLOOD WITH THE 1ST OCCURRENCE. THE 2ND AND 3RD OCCURRENCE OCCURRED PRIOR TO INITIATING TREATMENT, THE MACHINE KEPT ALARMING FOR AIR. ON THE 3RD OCCURRENCE STAFF CHANGED THE DIALYZER WITH A DIFFERENT LOT # AND TREATMENT WAS COMPLETED WITHOUT COMPLICATIONS. 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 11558883 ↗

Other Dialyzer, high permeability with or without sealed dialysate system devices

All Dialyzer, high permeability with or without sealed dialysate system devices →

Sources and updates

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