BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 10955682 · Received December 6, 2020

    Report

    Report Number
    9610987-2020-00009
    Event Type
    Injury
    Date Received
    December 6, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 21, 2020
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K140191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER INVESTIGATION REPORT ATTACHED IS ON RETAINED SAMPLES ONLY.

    Description of Event or Problem · 0

    ON (B)(6) 2020: PATIENT COMPLAINED OF ABDOMINAL PAIN DURING TREATMENT. PATIENT WAS ADMITTED TO THE ICU. FACILITY MANAGER QUESTIONED HOW THE DIALYZERS ARE STERILIZED, FACILITY MANAGER DOES NOT THINK THE ADVERSE EVENT WAS DUE TO THE DIALYZER SINCE THE PATIENT HAS BEEN USING THE ELISIO DIALYZERS FOR OVER A YEAR WITHOUT ISSUES. ADDITIONAL INFORMATION RECEIVED 11/23/2020: PATIENT (B)(6), 71-YEAR-OLD MALE, STARTED DIALYSIS TREATMENT AT 0704 ON (B)(6) 2020, COMPLETED TREATMENT FOR FOUR HOURS AS PRESCRIBED. LEFT THE UNIT TO GO BACK TO ASSISTED LIVING. PATIENT REPORTED OF LETHARGY BY NURSING. VETERAN REPORTS HE RETURNED FROM HD AND HIS LEFT ARM IS PAINFUL WITH REDUCED ROM (RANGE OF MOTION), A CHANGE FROM EARLIER THIS MORNING. HE NOTES HE FEELS "FAINT" AND HAS INDIGESTION WHICH HAS IMPROVED WITH TUMS. HE DENIES CHEST PAIN OR PRESSURE, RADIATING PAIN, JAW PAIN. FEELS CHILLED AND TIRED. VITALS: BP 136/69, P 87, 91% OXYGEN IN ROOM AIR AND TEMPERATURE OF 100.2. SENT VETERAN TO EMERGENCY ROOM. FROM EMERGENCY ROOM, PATIENT'S BLOOD SPECIMEN CONTINUES TO BE HEMOLYZED UPON ASPIRATION. PATIENT'S BLOOD PERSISTS WITH HEMOLYSIS WITH METHEMOGLOBINEMIA. METHEMOGLOBIN LEVEL OF 12.3. TREATMENT INFORMATION: NUMBER OF HOURS: 4. BFR: 400. DFR: 600. ANY MEDICATIONS ADMINISTERED: EPOGEN 5000 UNITS. PATIENT'S ACCESS: FISTULA. MACHINE: PHOENIX GAMBRO.

    Description of Event or Problem · 1

    ON 11/13/2020, PATIENT COMPLAINED OF ABDOMINAL PAIN DURING TREATMENT. PATIENT WAS ADMITTED TO THE ICU. FACILITY MANAGER QUESTIONED HOW THE DIALYZERS ARE STERILIZED, FACILITY MANAGER DOES NOT THINK THE ADVERSE EVENT WAS DUE TO THE DIALYZER SINCE THE PATIENT HAS BEEN USING THE ELISIO DIALYZERS FOR OVER A YEAR WITHOUT ISSUES. ADDITIONAL INFORMATION RECEIVED 11/23/2020: PATIENT (B)(6)., (B)(6)-YEAR-OLD MALE, STARTED DIALYSIS TREATMENT AT (B)(6) ON (B)(6) 2020, COMPLETED TREATMENT FOR FOUR HOURS AS PRESCRIBED. LEFT THE UNIT TO GO BACK TO ASSISTED LIVING. PATIENT REPORTED OF LETHARGY BY NURSING. VETERAN REPORTS HE RETURNED FROM HD AND HIS LEFT ARM IS PAINFUL WITH REDUCED ROM (RANGE OF MOTION), A CHANGE FROM EARLIER THIS MORNING. HE NOTES HE FEELS "FAINT", AND HAS INDIGESTION WHICH HAS IMPROVED WITH TUMS. HE DENIES CHEST PAIN OR PRESSURE, RADIATING PAIN, JAW PAIN. FEELS CHILLED AND TIRED. VITALS: BP 136/69, P 87, 91% OXYGEN IN ROOM AIR AND TEMPERATURE OF 100.2. SENT VETERAN TO EMERGENCY ROOM. FROM EMERGENCY ROOM, PATIENT'S BLOOD SPECIMEN CONTINUES TO BE HEMOLYZED UPON ASPIRATION. PATIENT'S BLOOD PERSISTS WITH HEMOLYSIS WITH METHEMOGLOBINEMIA. METHEMOGLOBIN LEVEL OF 12.3. TREATMENT INFORMATION: NUMBER OF HOURS: 4; BFR: 400; DFR: 600; ANY MEDICATIONS ADMINISTERED: EPOGEN 5000 UNITS; PATIENT'S ACCESS: FISTULA; MACHINE: PHOENIX GAMBRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421059 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-25H 20D02E

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization