BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO X HEMODIALYSIS SYSTEM

    MDR report key: 11378448 · Received February 25, 2021

    Report

    Report Number
    3010355846-2021-00057
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    January 31, 2021
    Report Date
    February 25, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. OUTSET MEDICAL, INC. FIELD SERVICE ENGINEER (FSE) REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2021, AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. THE SYSTEM CORRECTLY IDENTIFIED AND TRIGGERED ARTERIAL PRESSURE LOW ALARM THREE HOURS INTO TREATMENT; BLOOD PUMP STOPPED AND ALL OTHER COMPONENTS RESPONDED ACCORDINGLY. 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 BLOOD PUMP WAS STOPPED DUE TO LOW ARTERIAL PRESSURE ALARM DURING PATIENT'S TREATMENT. IT WAS REPORTED THAT THE NURSE DID NOT ATTEND OR INTERVENE FOR THE LOW ARTERIAL PRESSURE ALARM AND IT WENT ON FOR 20 MINUTES. TREATMENT WAS ENDED AND PATIENT'S BLOOD WAS DISCARDED. THE PATIENT LOST APPROXIMATELY 1 L OF BLOOD. NOTE 1: IT WAS REPORTED THAT THE PATIENT'S VENOUS NEEDLE BECAME DISLODGED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), AND WAS REPORTED TO BE UNSTABLE. NO FURTHER PATIENT INFORMATION IS AVAILABLE. BASED ON INTERNAL REVIEW OF THE LOG FILE DATA, IT IS NOT BELIEVED THAT THE TABLO DEVICE CAUSED THIS EVENT, RATHER THIS IS ATTRIBUTED TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274140 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 Hospitalization| L| R