BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 10036737 · Received May 7, 2020

    Report

    Report Number
    3010355846-2020-00018
    Event Type
    Injury
    Date Received
    May 7, 2020
    Date of Event
    January 20, 2020
    Report Date
    May 7, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K160866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OUTSET MEDICAL, INC. SYSTEMS ENGINEER HAS REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. NO RELATED SYSTEM ALARMS WERE FOUND TO HAVE OCCURRED DURING TREATMENT. THE DEVICE IS FUNCTIONING POST TREATMENT. A REVIEW OF PRODUCTION RECORDS FOR THIS UNIT DID NOT NOTE ANY MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO A PRODUCT EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RESPIRATORY ATTACK AND CODED DURING THE DIALYSIS TREATMENT. THE CLINICAL STAFF WAS ABLE TO REVIVE THE PATIENT AND THE PATIENT WAS SAID TO BE DOING OKAY. IT WAS NOTED THAT THE PATIENT LOST APPROXIMATELY 1 LITER OF BLOOD. IT IS NOT BELIEVED THAT THE TABLO DEVICE CAUSED THE EVENT, RATHER IT WAS DUE TO THE PATIENT'S PRE-EXISTING CONDITIONS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499593 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. TABLO X HEMODIALYSIS SYSTEM 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening