BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 17515639 · Received August 11, 2023

    Report

    Report Number
    3010355846-2023-00086
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    November 1, 2022
    Report Date
    August 11, 2023
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K190793
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE ON (B)(6) 2022 AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. DUE DILIGENCE WAS COMPLETED, AND OUTSET WAS NOT ABLE TO CONFIRM IF THE DEVICE CONTRIBUTED TO THE EVENT. A REVIEW OF PRODUCTION RECORDS FOR THIS UNIT DID NOT NOTE ANY MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO A PRODUCT. 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 A PATIENT CODED AND SUFFERED CARDIAC ARREST DURING TREATMENT ON TABLO. TREATMENT WAS COMPLETED AND THIS EVENT OCCURRED DURING BLOOD RINSE BACK. PATIENT WAS REVIVED. NOTE: CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT CODE; HOWEVER, THIS CANNOT BE CONFIRMED, OTHER THAN THAT PATIENT WAS NOTED AS DOING WELL AND HAD NO ONGOING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564637 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown