BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 17515654 · Received August 11, 2023

    Report

    Report Number
    3010355846-2023-00089
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    December 10, 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
    AL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 OF 10(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. 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 DURING DIALYSIS TREATMENT AND USER NEEDS COMPLETE TREATMENT INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. NOTE: CURRENTLY, IT IS UNKNOWN IF THE PATIENT CODING WAS RELATED TO TABLO OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868560 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other