BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 10455129 · Received August 26, 2020

    Report

    Report Number
    3010355846-2020-00025
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    August 2, 2020
    Report Date
    August 26, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. OUTSET MEDICAL, INC. FIELD SERVICE ENGINEER (FSE) 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 36 MINUTES INTO DIALYSIS TREATMENT, THE TREATMENT WAS ENDED DUE TO PATIENT'S CONDITION DETERIORATING THAT RESULTED IN A CODE BLUE (CARDIAC ARREST) BEING CALLED. THERE WAS NO BLOOD LOSS. TREATMENT WAS NOT RESUMED ON THE DAY OF, BUT PATIENT WAS TREATED THE FOLLOWING DAY DUE TO THE EVENT. IT WAS INDICATED THAT THE PATIENT WAS AGITATED AT THE START OF THE TREATMENT. THE CLINICAL STAFF RULED THE TABLO DEVICE OUT AS THE CAUSE FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918738 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| R