BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 10864178 · Received November 18, 2020

    Report

    Report Number
    3010355846-2020-00031
    Event Type
    Death
    Date Received
    November 18, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 18, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. OUTSET MEDICAL, INC. TECHNICAL SUPPORT SPECIALIST (TSS) 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 NONCONFORMANCE'S THAT WOULD CONTRIBUTE TO A PRODUCT EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, WHO WAS IN THE INTENSIVE CARE UNIT (ICU), CODED DURING A DIALYSIS TREATMENT. THE TREATMENT WAS STOPPED AND THEN THE PATIENT WAS REVIVED. IT WAS REPORTED THAT THE MEDICAL DOCTOR (MD) ORDERED TO RESUME TREATMENT; HOWEVER, THE PATIENT CODED AGAIN (BEFORE TREATMENT RESUMED) AND EXPIRED. THE PATIENT WAS STILL CONNECTED TO THE TABLO DEVICE WHEN THE EVENT OCCURRED; HOWEVER, THE SYSTEM WAS NOT RUNNING. IT IS NOT BELIEVED THAT THE TABLO DEVICE CONTRIBUTED TO THE PATIENT EXPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327943 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-0003000 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 Death