BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO CELLENTIA DIALYZER

    MDR report key: 7744786 · Received August 2, 2018

    Report

    Report Number
    9610987-2018-00008
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    April 20, 2018
    Report Date
    August 13, 2018
    Manufacturer
    NIPRO CORPORATION (ODATE)
    Product Code
    KDI
    PMA / PMN Number
    K160444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REPORT ATTACHED IS ON RETAINED SAMPLES ONLY.

    Description of Event or Problem · 1

    AFTER INITIATION OF OF THE PATIENT'S FIRST HEMODIALYSIS TREATMENT, THE PATIENT STARTED EXPERIENCING NAUSEA. TREATMENT WAS INTERRUPTED. TREATMENT WAS RESTARTED AND THE PATIENT STARTED VOMITING AND LOST CONSCIOUSNESS. TREATMENT WAS INTERRUPTED AGAIN, THE BLOODLINE AND DIALYZER WERE CHANGED, PATIENT CONTINUED TREATMENT WITHOUT FURTHER SYMPTOMS OR COMPLICATIONS. PATIENT'S PRIMARY DIAGNOSIS: CKD.

    Description of Event or Problem · 1

    AFTER INITIATION OF THE PATIENT'S FIRST HEMODIALYSIS TREATMENT, THE PATIENT STARTED EXPERIENCING NAUSEA. TREATMENT WAS INTERRUPTED. TREATMENT WAS RESTARTED AND THE PATIENT STARTED VOMITING AND LOST CONSCIOUSNESS. TREATMENT WAS INTERRUPTED AGAIN, THE BLOODLINE AND DIALYZER WERE CHANGED, PATIENT CONTINUED TREATMENT WITHOUT FURTHER SYMPTOMS OR COMPLICATIONS. PATIENT'S PRIMARY DIAGNOSIS: CKD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584384 NIPRO CELLENTIA DIALYZER DIALYZER KDI NIPRO CORPORATION (ODATE) DD+CT21H 17J23A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other