BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECC SMALL TUBING SET

    MDR report key: 3871321 · Received April 15, 2014

    Report

    Report Number
    2248146-2014-00052
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 17, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED, THEREFORE NO EVAL CAN BE PERFORMED. AN INVESTIGATION INTO THIS ISSUE HAS BEEN INITIATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TAPERFLEX TUBING ON THE VENOUS LINE IS LARGER IN DIAMETER THAN THE TAPERFLEX TUBING ON THE ARTERIAL LINE. THE PACK DRAWING SHOWS THIS TUBING AS IDENTICAL. THIS PACK WAS PRIMED AND WAITING TO BE USED FOR EMERGENCY CASES AT THE TIME OF THE EVENT, HOWEVER, NO PT USE WAS REPORTED. RELATED TO MFR REPORT NUMBERS 2248146-2014-00050, 00051, 00053.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230477 ECC SMALL TUBING SET CARDIOPULMONARY DEVICE DSP DATASCOPE CORP. BEQ-T 5208 16439-12

    Patients

    Seq Age Sex Outcome Treatment
    1