BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO X HEMODIALYSIS SYSTEM

    MDR report key: 11061062 · Received December 22, 2020

    Report

    Report Number
    3010355846-2020-00039
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 22, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. OUTSET MEDICAL, INC. TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020, AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. THE CONSOLE IS OPERATING AS INTENDED AFTER THE EVENT. A REVIEW OF PRODUCTION RECORDS FOR THIS UNIT DID NOT NOTE ANY MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO A PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CODED WITHIN SEVEN MINUTES INTO DIALYSIS TREATMENT ON A TABLO DEVICE. THE PATIENT WAS RESUSCITATED AND TREATMENT WAS RESCHEDULED. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, IT IS NOT BELIEVED THAT THE DEVICE CONTRIBUTED TO THE PATIENT EVENT; HOWEVER, IT WAS THOUGHT THAT THE PATIENT MAY HAVE BEEN ALLERGIC TO THE OPTIFLUX DIALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524140 TABLO X HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-0003000 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R