BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3/8" ECC PUMP PACK

    MDR report key: 4093120 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00380
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Report Date
    January 11, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE COMPLAINT DESCRIPTION AND REVIEW OF THE PACKAGING, IT IS BELIEVED THAT THE COMPLAINT CAN BE ATTRIBUTED TO OTHER ITEMS IN THE KIT BEING PACKAGED ON TOP OF THIS LINE AND BENDING IT OVER, CAUSING IT TO KINK. A PACKAGING CHANGE WAS APPROVED BY THE HOSP AND IMPLEMENTED TO NOT CONNECT THIS LINE TO THE OXYGENATOR AND IT WILL BE CONNECTED AT THE HOSP. THIS CHANGE WILL PREVENT THE PIGTAIL FROM GETTING BENT OVER IN THE KIT. THE CUSTOMER INDICATED THAT THEY WILL CHANGE OUT THIS LINE, IF NEEDED, ON ANY KITS WHERE THE PIGTAIL IS KINKED, UNTIL THEY EXHAUST THE EXISTING INVENTORY OF KITS IN THE PREVIOUS PACKAGING CONFIGURATION. (B)(4).

    Description of Event or Problem · 1

    ONE OF THE PIGTAILS IN THE 3/8" ECC PUMP PACK HAS LEAKED IN THREE DIFFERENT PUMP PACKS. THE PIGTAIL WAS IN THE SAME SPOT ALL THREE TIMES. THE LEAK WAS DISCOVERED ON TWO OF THE PACKS DURING PRIMING. ONE LEAKED DURING A CASE AND ALL THEY DID WAS TURN OFF THE PUMP FOR A FEW SECONDS AND CHANGED IT OUT. THE LEAK WAS WHERE THE TUBING GOES INTO THE MALE LUER ON THE PIGTAIL. IT LOOKED LIKE IT WAS BENT IN PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506781 3/8" ECC PUMP PACK CARDIOPULMONARY DEVICE DWE DATASCOPE CORP. BEQ-TOP 33700 13386-04

    Patients

    Seq Age Sex Outcome Treatment
    1