BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE

    MDR report key: 17515682 · Received August 11, 2023

    Report

    Report Number
    3010355846-2023-00096
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    May 18, 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
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. OUTSET FIELD SUPPORT ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED ISSUE. FSE REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2022 AND VERIFIED THAT CONSOLE IS OPERATING NORMALLY, THERE WAS NO ISSUE FOUND ON INTERNA OR EXTERNAL PARTS OF TABLO. 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 BLOOD LEAK FROM TOP THE OF DIALYZER DURING TREATMENT AND THE PATIENT LOSS WAS UP TO THREE LITERS BLOOD DUE TO A LEAK IN THE TOP OF THE DIALYZER. IT WAS REPORTED THAT APPROXIMATELY ONE-HOUR POST TREATMENT, PATIENT BLOOD LOSS AND ACIDOTIC STATE AND PROLONGED HYPOTENSION LEAD TO CODE. A DEFIBRILLATOR, AFTER THE TREATMENT HAD ENDED, WAS UTILIZED TO RESUSCITATE THE PATIENT. IT IS NOT BELIEVED THAT THE TABLO DEVICE WAS THE CAUSE OF THIS EVENT; RATHER, THE EVENT WAS ATTRIBUTED TO THE PATIENT, AND THE DIALYZER MALFUNCTIONED WITH A LEAK COMING FROM THE ARTERIAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869839 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 Required Intervention| L