BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARROW

    MDR report key: 146737 · Received January 30, 1998

    Report

    Report Number
    146737
    Event Type
    Other
    Date Received
    January 30, 1998
    Date of Event
    January 15, 1998
    Report Date
    January 22, 1998
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH INTRODUCER ONLY IN PLACE. TUBING BECAME DISCONNECTED AT SITE OF BLUE INTRODUCER CONNECTION. ESTIMATED 100-200CC BLOOD LOSS. PT DEVELOPED JUNCTIONAL RYTHM RECOVERED TO NSR FOR APPROX 10 MINS-DEVELOPED JUNCTIONAL RYTHM AGAIN AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW PA INTRODUCER DYB ARROW INTERNATIONAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other