BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 10955687 · Received December 6, 2020

    Report

    Report Number
    9610987-2020-00010
    Event Type
    Injury
    Date Received
    December 6, 2020
    Date of Event
    November 10, 2020
    Report Date
    December 22, 2020
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    UDI-DI
    00383790007122
    PMA / PMN Number
    K131935
    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: 2ND PATIENT SENT TO THE ICU AFTER DIALYSIS TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN DETAILS OF ADVERSE EVENT OR PATIENT SYMPTOMS. CLINICAL SPECIALIST WILL CONTINUE TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED 11/23/2020: PATIENT (B)(6), 75-YEAR-OLD FEMALE, STARTED DIALYSIS TREATMENT AT 630AM ON (B)(6) 2020, SET FOR 3.5H AS ORDERED, BP 104/65; HR 97. PATIENT COMPLAINED OF HEARTBURN DURING DIALYSIS. PATIENT STATED SHE HAS THIS OCCASIONALLY AT HOME AND TAKES SOME MEDS FOR IT. RENAL PHYSICIAN NOTIFIED OF PATIENT'S COMPLAINTS. PATIENT WAS STARTED ON OXYGEN 3L/NASAL CANNULA DUE TO COMPLAINTS OF SHORTNESS OF BREATH. O2 (OXYGEN) SATURATION CHECKED, 100% WITH OXYGEN. PATIENT WAS RESTING DURING HD WITH NO FURTHER DISTRESS. AT APPROXIMATELY AN HOUR AND A HALF INTO TREATMENT, RENAL PHYSICIAN WAS MAKING ROUNDS, SEEN AND EXAMINED PATIENT, WITH ORDERS TO STOP HD, DRAW LABS: CBC, LIPASE, TROPONIN, ELECTROLYTES AND SENT TO EMERGENCY ROOM FOR FURTHER EVALUATION/TREATMENT. HD ENDED 2.5 HOURS INTO TREATMENT. NEEDLES WERE REMOVED WITH NO SEVERE BLEEDING. BP 118/68; HR 98; TEMP: 97.8. TREATMENT INFORMATION: NUMBER OF HOURS: 2.5 ACCESS. BFR: 400. DFR: 600. HEPARIN: BOLUS. HOW LONG ON DIALYSIS: 2.5 HOURS INTO A 3.5 PRESCRIBED TREATMENT. DIALYZER: ELISIO 19H DIALYZER. MACHINE: PHOENIX GAMBRO.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE 2ND PATIENT SENT TO THE ICU AFTER DIALYSIS TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN DETAILS OF ADVERSE EVENT OR PATIENT SYMPTOMS. CLINICAL SPECIALIST WILL CONTINUE TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED 11/23/2020: PATIENT (B)(6), A (B)(6)-YEAR-OLD FEMALE, STARTED DIALYSIS TREATMENT AT 630AM ON (B)(6) 2020, SET FOR 3.5H AS ORDERED, BP 104/65; HR 97. PATIENT COMPLAINED OF HEARTBURN DURING DIALYSIS. PATIENT STATED SHE HAS THIS OCCASIONALLY AT HOME AND TAKES SOME MEDS FOR IT. RENAL PHYSICIAN NOTIFIED OF PATIENT'S COMPLAINTS. PATIENT WAS STARTED ON OXYGEN 3L/NASAL CANNULA DUE TO COMPLAINTS OF SHORTNESS OF BREATH. O2(OXYGEN) SATURATION CHECKED, 100% WITH OXYGEN. PATIENT WAS RESTING DURING HD WITH NO FURTHER DISTRESS. AT APPROXIMATELY AN HOUR AND A HALF INTO TREATMENT, RENAL PHYSICIAN WAS MAKING ROUNDS, SEEN AND EXAMINED PATIENT, WITH ORDERS TO STOP HD, DRAW LABS: CBC, LIPASE, TROPONIN, ELECTROLYTES AND SENT TO EMERGENCY ROOM FOR FURTHER EVALUATION/TREATMENT. HD ENDED 2.5 HOURS INTO TREATMENT. NEEDLES WERE REMOVED WITH NO SEVERE BLEEDING. BP 118/68; HR 98; TEMP: 97.8. TREATMENT INFORMATION: NUMBER OF HOURS: 2.5 ACCESS; BFR: 400; DFR: 600; HEPARIN: BOLUS; HOW LONG ON DIALYSIS: 2.5 HOURS INTO A 3.5 PRESCRIBED TREATMENT. DIALYZER: ELISIO 19H DIALYZER; MACHINE: PHOENIX GAMBRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421063 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-19H 19K21B 00383790007122

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization