BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PACK

    MDR report key: 4093112 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00341
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LINES WERE SENT TO THE MANUFACTURER FOR EVAL. THE MANUFACTURER REVIEWED THE TUBING USING A POWER MICROSCOPE AND NOTED THAT THE SLIT WAS JAGGED. IN ADDITION, THEY NOTED AN ABRASIVE PATTERN ON THE TUBING, APPROXIMATELY 9 INCHES IN LENGTH, ALONG THE LENGTH OF THE TUBING WHICH LINES UP WITH THE JAGGED SLIT. BASED UPON THEIR REVIEW, THEY DO NOT BELIEVE THAT ABRASIVE PATTERN OR THAT TYPE OF SLIT WOULD HAVE BEEN CAUSED BY ANY OF THEIR MANUFACTURING PROCESSES. ALL CURRENT INVENTORY WAS INSPECTED AND NONE OF THE TUBES IN STOCK SHOWED ANY SIGNS OF SLITS OR RUPTURE LINES. IT WAS ALSO REPORTED THAT THE PERCEIVED DEFECTS ON THE OTHER PIECES WERE BAG MARKS. THESE ARE CREATED WHEN THE WARM TUBING IS NOT DRIED PROPERLY LEAVING MARKS BEFORE BEING PLACED INTO THE BAGS FOR SHIPPING. THEY DO NOT BELIEVE THAT THESE MARKS ARE RELATED TO THE DEFECT REPORTED. BASED UPON THE REVIEW BY THE MANUFACTURER, IT IS UNK AT THIS TIME AS TO WHAT THE SPECIFIC ROOT CAUSE WAS OF THE RUPTURE, ALTHOUGH THE JAGGED SLIT BEING IN LINE WITH THE ABRASIVE PATTERN SUGGESTS THAT THE PUMP MAY HAVE CONTRIBUTED TO THE SLIT. AS FOR THE BAG MARKS, THE MANUFACTURER HAS REVISED THEIR PROCESS TO ADDRESS THIS ISSUE. A CHANGE HAS BEEN MADE TO THIS KIT, REPLACING THE TAPERFLEX LINE WITH REGULATOR PUMP TUBING FOR ALL FUTURE BUILDS. (B)(4).

    Description of Event or Problem · 1

    THE TERRITORY MGR RECEIVED A CALL FROM A PERFUSIONIST STATING THE RACEWAY BOOT RUPTURED DURING A CARDIOPULMONARY BYPASS PROCEDURE. THE PT HAD BEEN ON THE PUMP FOR 1.5 HRS WHEN THE BOOT STARTED TO LEAK. THE TERRITORY MGR ASKED HIM TO HOLD THE PRODUCT FOR PICKUP/SHIPMENT BACK TO THE MANUFACTURER. THE PERFUSIONIST DID NOT REPORT OR FILL OUT AN INCIDENT REPORT BECAUSE HE DID NOT CHANGE OUT THE BOOT. IT WAS TOWARDS THE END OF THE CASE, SO THE PERFUSIONIST LOWERED THE FLOWS FROM 3.2 1PM TO 2.9 1PM, AND PLACED TOWELS UNDER THE PUMP TO CATCH THE SHED BLOOD. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506749 CUSTOM PACK CARDIOPULMONARY DEVICE DTR DATASCOPE CORP BO-T 25102 14669-09

    Patients

    Seq Age Sex Outcome Treatment
    1