BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSION PACK

    MDR report key: 4093125 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00390
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP INDICATED THAT THE TIE WRAP (LINE 5 CONNECTION E) COULD BE ROTATED WITH VERY LITTLE PRESSURE AROUND THE TUBING IT WAS SECURING. SINCE NO PRODUCT WAS RETUNED FOR EVAL, BASED ON THE COMPLAINT, PHOTOGRAPHS AND FEEDBACK FROM THE HOSP, THE TIE WRAP EITHER WAS APPLIED TO THE TUBE INCORRECTLY OR WAS NOT INSPECTED PROPERLY. AS FOR THE LEAKS OCCURRING AT THE IN/OUT CONNECTIONS TO THE PRE-BYPASS FILTER, NO CAUSE DETERMINATION CAN BE MADE SINCE NO OTHER INFO OR KITS WERE SUPPLIED. THE HOSP HAS REQUESTED A DESIGN CHANGE TO ADD TIE WRAPS TO THESE CONNECTION ON FUTURE KITS, WHICH IS CURRENTLY IN PROCESS. THE HOSP IS NOT GOING TO RETURN ANY KITS AND WILL NOT REQUIRE US TO REVIEW STOCK. THEY HAVE ADVISED THAT THEY WILL ADD AN ADD'L TIE WRAP, IF REQUIRED. THE LOOSE TIE WRAP ISSUE WAS DISCUSSED WITH THE MANUFACTURING PERSONNEL AND THEY WERE RE-TRAINED ON THE PROPER MANUFACTURING AND INSPECTION METHODS FOR TIE WRAP CONNECTIONS. (B)(4).

    Description of Event or Problem · 1

    THE Y-CONNECTORS ON LINE #5 LEAKED SLIGHTLY WHEN THEY WERE COMING OFF PUMP AT THE END OF THE CASE. DID NOT EFFECT THE CASE AND THE PACK WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506761 PERFUSION PACK CARDIOPULMONARY DEVICE DWF DATASCOPE CORP BO-TOP 15500 13870-08

    Patients

    Seq Age Sex Outcome Treatment
    1