BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 19075362 · Received April 9, 2024

    Report

    Report Number
    3010355846-2024-00100
    Event Type
    Death
    Date Received
    April 9, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 9, 2024
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS CREATED TO CORRECT INFORMATION INITIALLY SUBMITTED FOR: A3A. SEX.

    Additional Manufacturer Narrative · 0

    H3/H6: FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE (IFU) WITH THE TABLO SYSTEM INCLUDES, BUT ARE NOT LIMITED TO, OTHER, MORE SERIOUS, COMPLICATIONS ARISING FROM DIALYSIS, SUCH AS HEMORRHAGE, AIR EMBOLISM, ACIDOSIS, ALKALOSIS OR HEMOLYSIS, CAN CAUSE SERIOUS PATIENT INJURY OR DEATH. THERE IS NO INDICATION AT THIS TIME THAT TABLO CAUSED OR CONTRIBUTED TO THIS EVENT, HOWEVER OUTSET HAS NOT BEEN ABLE TO CONFIRM THE CAUSALITY OF THE EVENT, AS OUTSET HAVE NOT RECEIVED CONFIRMATION. A REVIEW OF PRODUCTION RECORDS FOR THIS UNIT DID NOT NOTE ANY MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO A PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO CARDIAC ARREST, REPORTER IS NOT SURE IF IT WAS DURING OR AFTER TREATMENT AS THE HOSPITAL DOCUMENTATION IS CONFLICTING FROM EMERGENCY MEDICAL TECHNICIANS (EMTS). PATIENT WAS UNCONSCIOUS FROM CARDIAC EVENT, EMT DISPATCHED AND ATTEMPTED 40 MINUTES RESUSCITATION, PATIENT WAS TRANSPORTED TO HOSPITAL AND REMAINED THERE UNTIL SHE EXPIRED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269477 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death