NIPRO Cellentia™-H Hemodialyzer Cellentia™-15HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383790004381), received between Jul 19, 2019 and Jul 19, 2019 — classified as 2 deaths.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

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

• DeathJul 19, 2019Device Alarm System

  PATIENT WAS IN THE HOSPITAL AND STARTED AS AN ACUTE KIDNEY INJURY PATIENT. APPROXIMATELY 4.5HRS INTO ACUTE HEMODIALYSIS TREATMENT (TREATMENT INITIATED AT 14:42) AT THE HOSPITAL, MACHINE ALARMED FOR BLOOD LEAK, IMMEDIATELY PRIOR TO THE ALARM HE WAS STARTED ON A NITROGLYCERIN DRIP AS WELL AS NICARDIPINE AND SEEMS TO HAVE BEEN ON THE HEMOPURE, FENTANYL AND MIDAZOLAM ALL DAY, PATIENT DEVELOPED A SEVERE SPIKE IN BLOOD PRESSURE PRIOR TO THE ALARM (PATIENT REMOVED FROM TREATMENT AT 19:35). DIALYZER WAS NOT TESTED FOR BLOOD LEAK TO CONFIRM POSITIVE BLOOD LEAK. DURING TREATMENT: PATIENT WAS NOTED TO BE HYPERTENSIVE IN WITH SYSTOLIC IN THE 180-190S AROUND 6:45PM. THIS HAPPENED ACUTELY, HIS BP WAS AROUND 120/60 FOR MOST OF THE DAY. HIS BP RAPIDLY WENT UP TO 260S SBP WITHIN 15 MINUTES. LIKELY SECONDARY TO HEMOPURE (THE DRUG IS KNOWN TO HAVE VASOACTIVE EFFECTS AND ALSO CAUSE VOLUME OVERLOAD) AND EPO (40,000 UNITS) THAT HE GOT EARLIER TODAY. STARTED NITRO DRIP TO TITRATE FOR SBP 130-160 MMHG WITHIN 15 MIN OF NOTING HYPERTENSION. AROUND 7:10 PM PATIENT'S VENTILATOR STARTED TO ALARM AND HIS MINUTE VENTILATION WAS NOTED TO HAVE DIPPED ACUTELY FROM 14-18 TO 7. HE ALSO WAS NOTED TO HAVE STOPPED MAKIN

  Patient problems: Death; Decreased Respiratory Rate; Edema; High Blood Pressure/ Hypertension; Hypoventilation

  MAUDE report 8809373 ↗
• DeathJul 19, 2019Leak/Splash; Leak/Splash

  PATIENT WAS IN THE HOSPITAL AND STARTED AS AN ACUTE KIDNEY INJURY PATIENT. APPROXIMATELY 4.5HRS INTO ACUTE HEMODIALYSIS TREATMENT (TREATMENT INITIATED AT 14:42) AT THE HOSPITAL, MACHINE ALARMED FOR BLOOD LEAK, IMMEDIATELY PRIOR TO THE ALARM HE WAS STARTED ON A NITROGLYCERIN DRIP AS WELL AS NICARDIPINE AND SEEMS TO HAVE BEEN ON THE HEMOPURE, FENTANYL AND MIDAZOLAM ALL DAY, PATIENT DEVELOPED A SEVERE SPIKE IN BLOOD PRESSURE PRIOR TO THE ALARM (PATIENT REMOVED FROM TREATMENT AT 19:35). DIALYZER WAS NOT TESTED FOR BLOOD LEAK TO CONFIRM POSITIVE BLOOD LEAK. DURING TREATMENT: PATIENT WAS NOTED TO BE HYPERTENSIVE IN WITH SYSTOLIC IN THE 180-190S AROUND 6:45PM. THIS HAPPENED ACUTELY,HIS BP WAS AROUND 120/60 FOR MOST OF THE DAY. HIS BP RAPIDLY WENT UP TO 260S SBP WITHIN 15 MINUTES. LIKELY SECONDARY TO HEMOPURE (THE DRUG IS KNOWN TO HAVE VASOACTIVE EFFECTS AND ALSO CAUSE VOLUME OVERLOAD) AND EPO (40,000 UNITS) THAT HE GOT EARLIER TODAY. STARTED NITRO DRIP TO TITRATE FOR SBP 130-160 MMHG WITHIN 15 MIN OF NOTING HYPERTENSION. AROUND 7:10 PM PATIENT'S VENTILATOR STARTED TO ALARM AND HIS MINUTE VENTILATION WAS NOTED TO HAVE DIPPED ACUTELY FROM 14-18 TO 7. HE ALSO WAS NOTED TO HAVE STOPPED MAKING

  Patient problems: Death

  MAUDE report 8809333 ↗