BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE

    MDR report key: 17515665 · Received August 11, 2023

    Report

    Report Number
    3010355846-2023-00090
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    December 30, 2022
    Report Date
    August 11, 2023
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    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. TABLO USER MANUAL HAS THE FOLLOWING WARNING: CHECK ALL BLOODLINES FOR LEAKS AFTER THE TREATMENT HAS STARTED. KEEP ACCESS SITES UNCOVERED AND MONITORED. IMPROPER BLOODLINE CONNECTIONS OR NEEDLE DISLODGEMENTS CAN RESULT IN EXCESSIVE BLOOD LOSS, SERIOUS INJURY, AND DEATH. MACHINE ALARMS MAY NOT OCCUR IN EVERY BLOOD LOSS SITUATION. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2022 AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. THE CONSOLE OPERATED AS INTENDED. DUE DILIGENCE WAS COMPLETED, AND OUTSET WAS NOT ABLE TO CONFIRM CAUSALITY DUE TO LACK OF INFORMATION. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER RETROSPECTIVE REVIEW AND REASSESSED AS REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BLOOD LEAK DURING HOME PATIENT TREATMENT AND NO ALARM OCCURRED. TREATMENT WAS ENDED AND THERE WAS AN ESTIMATED 400 ML BLOOD LOSS. HOME PATIENT DID NOT FEEL WELL, HE FELT WEAK, AND HAD TO GO TO HOSPITAL AND PERFORM BLOOD TEST TO EVALUATE. ON (B)(6) 2023 IT WAS NOTED THAT THE HOME PATIENT IS FEELING BETTER AND FELT LIKE HE WENT THROUGH SOME SERIOUS TRAUMA. NOTE: CURRENTLY, IT IS UNKNOWN IF THE PATIENT EVENT WAS RELATED TO TABLO OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868571 TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other