BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTILAB SERIES II ERGO-IDC

    MDR report key: 16015359 · Received December 19, 2022

    Report

    Report Number
    MW5113854
    Event Type
    Death
    Date Received
    December 19, 2022
    Date of Event
    November 23, 2022
    Report Date
    December 8, 2022
    Manufacturer
    UNETIXS VASCULAR, INC
    Product Code
    JAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022- PATIENT TAKEN TO RADIOLOGY FOR ABI. FT TECH AND AGENCY TECH COMPLETING EXAM TOGETHER. ABI AIR LINE CONNECTED TO RIGHT-SALINE LOCK LOCATED IN RIGHT AC. ERROR RECOGNIZED WHEN CUFF WAS NOT INFLATING AND AIR WAS NOT REACHING MAXIMUM POINT. EXAM STOPPED AND LINES DISCONNECTED. PATIENT REPORTS FEELING NAUSEOUS THEN SUFFERS CARDIAC ARREST. PATIENT PLACED ON LEFT SIDE, LN TRENDELENBURG POSITION. CODE BLUE INITIATED. ON (B)(6) 2022 1452 CT CHEST WITHOUT CONTRAST: EXTENSIVE PORTAL VENOUS GAS IS IDENTIFIED THROUGHOUT THE LIVER WITH PATCHY GAS AND AIR-FLUID LEVELS WITHIN THE SUPERIOR AND INFERIOR VENA CAVA, RIGHT ATRIUM AND VENTRICLE, SUBCLAVIAN VEINS AND PULMONARY ARTERIES. A SMALL AMOUNT OF GAS IS PRESENT WITHIN THE AORTIC ARCH AS WELL. DIAGNOSIS HE UNDER WENT ABLS TODAY AND THERE WAS AN ERROR DURING THE TEST AND PRESSURIZED AIR WAS INJECTED INTO THE PERIPHERAL IV. THE PATIENT SUBSEQUENTLY HAD A CARDIAC ARREST SECONDARY TO MASSIVE IATROGENIC AIR EMBOLISM. - DOCUMENTED BY DR. (B)(6)/CC REVIEW OF INCIDENT RELATED TO MACHINE : ABI AIR-LINE MALE CONNECTOR EASILY FITS INTO BOTH THE INTENDED BLOOD PRESSURE CUFF AND THE SALINE HELPLOCK CONNECTED TO THE IV SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858706 MULTILAB SERIES II ERGO-IDC MONITOR,ULTRASONIC,NONFETAL JAF UNETIXS VASCULAR, INC 11949-0000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death