BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OH PACK WITH VKMO 70000

    MDR report key: 4090103 · Received August 18, 2014

    Report

    Report Number
    2248146-2014-00351
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    June 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LEAKING OXYGENATOR WAS RETURNED FOR EVALUATION AND TESTED TO DETERMINE THE LOCATION/SOURCE OF THE LEAK. ACCORDING TO THE USER FEEDBACK THE LEAK WAS BELIEVED TO HAVE BEEN FROM THE JOINT EXITING THE ARTERIAL PORT BUT COULD NOT BE CONFIRMED. THE LEAK OCCURRED TOWARDS THE END OF THE BYPASS AND ITS LOCATION COULD NOT BE CONFIRMED WHEN THE KIT WAS TAKEN "OFF PUMP" AND THE TUBING WAS WIPED DOWN. THE ASSEMBLY WAS SUBMERGED IN A BUCKET OF AMBIENT TEMPERATURE WATER AND SUBJECTED TO AIR PRESSURE THAT WAS GRADUALLY INCREASED TO A MAXIMUM OF APPROXIMATELY 22 PSI. THERE WERE NO LEAKS FOUND IN THE JOINT OR "PLASTIC" BODY OF THE OXYGENATOR/ARTERIAL PORT AS THE PRESSURE WAS INCREASED. ACCORDING TO THE DRAWING, THE KIT IN QUESTION IS SHIPPED TO THE CUSTOMER WITH "CAPS" ON BOTH THE "VENOUS" AND "ARTERIAL" PORTS OF THE OXYGENATOR. THE CAPS ARE SUBSEQUENTLY REMOVED BY HOSP PERSONNEL WHEN THE JOINTS ARE ASSEMBLED DURING THE SETUP OF THE KIT. THE LIKELY CAUSE OF THE LEAK IS THE IMPROPER ASSEMBLY OF THE JOINT DURING THE KIT SETUP. SINCE THE SETUP IS PERFORMED AT THE HOSP NO ADDITIONAL INVESTIGATIVE ACTION WILL BE PURSUED. COMPLAINTS RELATED TO THE "ARTERIAL" PORT WILL BE MONITORED TO DETERMINE IF THE ISSUE IS RECURRING. SHOULD A RECURRING PATTERN DEVELOP, THE ISSUE WILL BE RE-VISITED AND ADDRESSED AT THE APPROPRIATE TIME. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING OUT OF THE ARTERIAL PORT OF THE HMO70000 THAT IS WITHIN A CUSTOM PACK. THIS OCCURRED AFTER CPB WAS DISCONTINUED, BUT DURING VOLUME ADMINISTRATION. PORT WAS STILL INTACT, BUT A 2 INCH POOL OF BLOOD WAS DISCOVERED BELOW THE ARTERIAL PORT. THE ARTERIAL PORT ALSO SEEMED TO HAVE DRIED BLOOD ON IT WHERE THE LEAK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496308 OH PACK WITH VKMO 70000 CARDIOPULMONARY DEVICE DSP DATASCOPE CORP BO-TOP 21709 13822-02

    Patients

    Seq Age Sex Outcome Treatment
    1