BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO ELISIO-H HEMODIALYZER

    MDR report key: 12590749 · Received October 7, 2021

    Report

    Report Number
    9610987-2021-00010
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    August 31, 2021
    Report Date
    March 18, 2022
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT ATTACHED IS ON RETAINED SAMPLES BY THE MANUFACTURER. ACTUAL USED SAMPLES WILL BE RETURNED BY THE USER.

    Description of Event or Problem · 0

    2 EVENTS (SAME PATIENT, SAME DAY) OF BLOOD LEAKAGE ALARM OCCURRED DURING DIALYSIS TREATMENT: 1ST INCIDENT: AT 10AM, DURING DIALYSIS SESSION, MACHINE ALARMED FOR BLOOD LEAKAGE AND CONFIRMED BY TEST. DIALYSIS SESSION WAS INTERRUPTED. PATIENT LOST AROUND 300ML OF BLOOD. 2ND INCIDENT: PATIENT WAS CONNECTED AGAIN TO ANOTHER MACHINE SET UP WITH NEW BLOOD CIRCUIT, AT 11:20AM, MACHINE ALARMED FOR BLOOD LEAKAGE, PATIENT LOST AROUND 300ML OF BLOOD. PATIENT WAS NOT CONNECTED AGAIN TO CONTINUE TREATMENT AND RESCHEDULED FOR NEXT DAY DIALYSIS SESSION. DIALYSIS SETTINGS: BLOOD FLOW RATE: 350, DIALYSATE FLOW RATE: 500, HEPARIN VOLUME: LOVENOX 0.4, TREATMENT PLAN DURATION: 4HOURS, TREATMENT RECEIVED: 1HR AND 8 MIN ON 1ST ATTEMPT, 52 MINUTES FOR 2ND ATTEMPT. OTHER DEVICES USED: FRESENIUS DIALYSIS MACHINE, FRESENIUS BLOODLINE, NEO SP802 SUPERCATH NEEDLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION REPORT IS ON RETAINED SAMPLES BY THE MANUFACTURER. ACTUAL USED SAMPLES WILL BE RETURNED BY THE USER.

    Description of Event or Problem · 1

    2 EVENTS (SAME PATIENT, SAME DAY) OF BLOOD LEAKAGE ALARM OCCURRED DURING DIALYSIS TREATMENT: 1ST INCIDENT: AT 10AM, DURING DIALYSIS SESSION, MACHINE ALARMED FOR BLOOD LEAKAGE AND CONFIRMED BY TEST. DIALYSIS SESSION WAS INTERRUPTED. PATIENT LOST AROUND 300ML OF BLOOD. 2ND INCIDENT: PATIENT WAS CONNECTED AGAIN TO ANOTHER MACHINE SET UP WITH NEW BLOOD CIRCUIT, AT 11:20AM, MACHINE ALARMED FOR BLOOD LEAKAGE, PATIENT LOST AROUND 300ML OF BLOOD. PATIENT WAS NOT CONNECTED AGAIN TO CONTINUE TREATMENT AND RESCHEDULED FOR NEXT DAY DIALYSIS SESSION. DIALYSIS SETTINGS: BLOOD FLOW RATE: 350, DIALYSATE FLOW RATE: 500, HEPARIN VOLUME: LOVENOX 0.4, TREATMENT PLAN DURATION: 4HOURS, TREATMENT RECEIVED: 1HR AND 8 MIN ON 1ST ATTEMPT, 52 MINUTES FOR 2ND ATTEMPT. OTHER DEVICES USED: FRESENIUS DIALYSIS MACHINE, FRESENIUS BLOODLINE, NEO SP802 SUPERCATH NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492685 NIPRO ELISIO-H HEMODIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-21H 21D15C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other