BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIC COMPONENT: 7 FR X 6

    MDR report key: 2657633 · Received July 10, 2012

    Report

    Report Number
    1036844-2012-00192
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    May 30, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A MEDWATCH REPORT THAT THE INTENDED PROCEDURE WAS A LIVER TRANSPLANT. THE PT SUFFERED AN AIR EMBOLISM WHEN IV TUBING WAS BEING REMOVED FROM THE MICROCLAVE CLEAR CAP CONNECTOR (MFG BY ICU MEDICAL INC) WHICH HAD BEEN ATTACHED TO A SINGLE LUMEN INFUSION CATHETER (SLIC) THAT HAD BEEN INSERTED IN A TWO LUMEN CENTRAL VENOUS ACCESS DEVICE (B)(4). THE MICROCLAVE CONNECTOR BECAME DISCONNECTED FROM THE SINGLE LUMEN INFUSION CATHETER WHEN THE TUBING WAS BEING REMOVED AND FELL OFF. AIR CAME INTO THE LINE AND THE PT BECAME SYMPTOMATIC FOR AN AIR EMBOLISM. PT WENT INTO CARDIAC ARREST, SUSTAINED NEUROLOGICAL INJURY AND WAS PLACED IN OUR NICU (NEURO ICU). THE PT IS NOW IN REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIC COMPONENT: 7 FR X 6 CRITICAL CARE PSI PRODUCTS DYB ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MICROCLAVE CLEAR CAP CONNECTOR (MFG BY ICU| MEDICAL INC): (B)(4)