BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 17515680 · Received August 11, 2023

    Report

    Report Number
    3010355846-2023-00095
    Event Type
    Death
    Date Received
    August 11, 2023
    Date of Event
    April 23, 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
    FL, 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 (B)(6) 2022 AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. NO ALLEGATION AGAINST TABLO; HOWEVER, DUE DILIGENCE WAS NOT ABLE TO CONFIRM CAUSALITY. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS CREATED TO CORRECT INFORMATION INITIALLY SUBMITTED FOR: A2. AGE. A3A. SEX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN 85YO MALE PATIENT HAD RESPIRATORY DISTRESS APPROXIMATELY 14 MINUTES INTO TREATMENT. CARE PERSONNEL INITIATED CARDIOPULMONARY RESUSCITATION (CPR); HOWEVER, THE PATIENT EXPIRED. PRIOR TO TREATMENT, THE PATIENT'S CONDITION WAS REPORTED TO BE FRAIL, DECLINING AND PENDING HOSPICE. THERE WAS NO ALLEGED MALFUNCTION OF TABLO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869837 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death