NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-15HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00383790007092), received between Oct 2, 2018 and Dec 28, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2018Leak/Splash; Leak/Splash

  27 MIN INTO THE DIALYSIS TREATMENT, THE MACHINE ALARMED FOR MINOR BLOOD LEAK, THE STAFF TESTED IT WITH A BLOOD LEAK TEST STRIP AND RESULTS WERE POSITIVE. THEY WERE UNABLE TO RETURN THE PATIENT'S BLOOD, THE MACHINE WAS SWITCHED, AND WHILE SETTING UP NEW DIALYZER AND BLOODLINES, THE PATIENT INFILTRATED AND COULD NOT RESTART TREATMENT. PATIENT LEFT THE DIALYSIS UNIT STABLE, TEMPERATURE WAS 96.5 RIGHT AFTER MACHINE ALARMED FOR BLOOD LEAK, TEMPERATURE WAS 96.4 WHEN DISCHARGED FROM UNIT. SINCE THE STAFF WAS UNABLE TO RETURN THE PATIENT'S BLOOD, 300ML OF BLOOD WAS LOST. PATIENT'S PHYSICIAN AND CLINICAL COORDINATOR WERE AWARE OF THE ISSUE. PHYSICIAN INCREASED DOSE OF VENOFER AND ORDER TO RECHECK HEMOGLOBIN LEVEL ON NEXT SCHEDULED TREATMENT. PATIENT'S REGULAR DIALYSIS TREATMENT WAS RESCHEDULED FOR (B)(6) 2018 DUE TO INFILTRATION, STAFF WAS UNABLE TO DRAW LABS. PATIENT IS BEING SCHEDULED FOR VASCULAR ACCESS INTERVENTION (ANGIOPLASTY) ON (B)(6) 2018. TREATMENT WAS STARTED AT 6:07 AM AND MEDICATION WAS GIVEN AT 6:28 AM. PATIENT'S ACCESS IS A LEFT UPPER AV FISTULA. TREATMENT ORDERS: 210 MINS TREATMENT, 3K, 2.5CA, BICRAB 32, SODIUM 138, BFR 400, DFR 600, HEPARIN BOLUS 2000 UNITS AND 600 UNITS/HO

  Patient problems: Blood Loss

  MAUDE report 8202384 ↗
• InjuryDec 27, 2018Leak/Splash; Device Displays Incorrect Message

  27 MIN INTO THE DIALYSIS TREATMENT, THE MACHINE ALARMED FOR MINOR BLOOD LEAK, THE STAFF TESTED IT WITH A BLOOD LEAK TEST STRIP AND RESULTS WERE POSITIVE. THEY WERE UNABLE TO RETURN THE PATIENT'S BLOOD, THE MACHINE WAS SWITCHED, AND WHILE SETTING UP NEW DIALYZER AND BLOODLINES, THE PATIENT INFILTRATED AND COULD NOT RESTART TREATMENT. PATIENT LEFT THE DIALYSIS UNIT STABLE, TEMPERATURE WAS 96.5 RIGHT AFTER MACHINE ALARMED FOR BLOOD LEAK, TEMPERATURE WAS 96.4 WHEN DISCHARGED FROM UNIT. SINCE THE STAFF WAS UNABLE TO RETURN THE PATIENT'S BLOOD, 300 ML OF BLOOD WAS LOST. PATIENT'S PHYSICIAN AND CLINICAL COORDINATOR WERE AWARE OF THE ISSUE. PHYSICIAN INCREASED DOSE OF VENOFER AND ORDER TO RECHECK HEMOGLOBIN LEVEL ON NEXT SCHEDULED TREATMENT. PATIENT'S REGULAR DIALYSIS TREATMENT WAS RESCHEDULED FOR (B)(6) 2018 DUE TO INFILTRATION, STAFF WAS UNABLE TO DRAW LABS. PATIENT IS BEING SCHEDULED FOR VASCULAR ACCESS INTERVENTION (ANGIOPLASTY) ON (B)(6) 2018. TREATMENT WAS STARTED AT 6:07 AM AND MEDICATION WAS GIVEN AT 6:28 AM. PATIENT'S ACCESS IS A LEFT UPPER AV FISTULA. TREATMENT ORDERS: 210 MINS TREATMENT, 3K, 2.5 CA, BICARB 32, SODIUM 138, BFR 400, DFR 600, HEPARIN BOLUS 2000 UNITS AND 600 UNITS/

  Patient problems: Blood Loss; Infiltration into Tissue

  MAUDE report 8201183 ↗
• InjuryOct 2, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON JUNE 29, 2018 THE MANUFACTURER WAS ADVISED OF AN ADVERSE EVENT THAT OCCURRED IN (B)(6) 2016 (EXACT DATE UNKNOWN), WHILE USING A DIALYZER MODEL THAT WAS NOT SIMILAR TO ANY MODEL SOLD IN THE UNITED STATES. COMPLAINT DETAILS: THE PATIENT WAS USING A CTA DIALYZER AND SHE WAS CHANGED TO NIPRO PES DIALYZER. AFTER THE CHANGE, THE PATIENT HAD DETERIORATION OF THE SKIN AND ITCHING. ON (B)(6) OF 2017, AFTER INITIATION OF TREATMENT, THE PATIENT'S BLOOD PRESSURE AND OXYGEN LEVEL DECREASED. THE PATIENT WAS HOSPITALIZED, HAD FEVER AND SKIN RASH WITH INCREASING EOSINOPHILS AND HIGH LEVEL OF IGE. ALLERGY TO PES DIALYZER WAS SUSPECTED. THE DIALYZER WAS CHANGED TO THE CTA DIALYZER. DIALYSIS WAS THEN COMPLETED WITHOUT SYMPTOMS. EOSINOPHILS AND IGE LEVELS DECREASED, SKIN ITCHING WAS IMPROVED. THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL, DIALYSIS HAS CONTINUED TO BE STABLE USING THE CTA DIALYZER. ON SEPTEMBER 28, 2018, THE MANUFACTURER WAS ADVISED THAT THE PRODUCT CODE REPORTED WAS INCORRECT. ONCE CORRECTED, IT WAS DETERMINED THAT THE CORRECT CODE HAS A SIMILAR MODEL SOLD IN THE UNITED STATES. MDR REPORTABILITY WAS THEN INITIATED.

  Patient problems: Fever; Loss of consciousness; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Rash

  MAUDE report 7927938 ↗