BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL PATIENT ECC

    MDR report key: 3810005 · Received May 1, 2014

    Report

    Report Number
    2248146-2014-00067
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    January 25, 2014
    Report Date
    April 1, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE A ROOT CAUSE COULD NOT BE IDENTIFIED. DEVICE HISTORY WAS REVIEWED AND NO NON-CONFORMANCES WERE FOUND RELATED TO THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED OR THE DEVICE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE TUBING CAME OFF THE VENOUS SIDE FO THE OXYGENATOR AND WAS IMMEDIATELY PLACED ON. AIR WAS REMOVED FORM THE CIRCUIT AND ALBUMIN WAS GIVEN TO REPLACE VOLUME LOSS UNTIL BLOOD COULD BE ORDERED. PRE/POST MEMBRANE PRESSURES WERE 400, BEFORE TUBING DISCONNECTION AND DISCUSSION OF OXYGENATOR CHANGE HAD ALREADY BEEN TAKING PLACE. THE PATIENT REQUIRED PROLONGED RESUSCITATION WHICH LED TO DISCUSSION WITH THE FAMILY ABOUT WITHDRAWAL OF SUPPORT. THE FAMILY MADE THE DECISION TO WITHDRAWAL. THE OXYGENATOR WAS NOT SAVED FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261997 SMALL PATIENT ECC CARDIOPULMONARY DEVICE DWF DATASCOPE CORP. BO-TOP 4601 13926-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention