BEUDAMED
    FDA Adverse Event Other Summary report: N

    SC MIDWEST REG LXNGTN KY 1

    MDR report key: 2187539 · Received July 22, 2011

    Report

    Report Number
    1718850-2011-00095
    Event Type
    Other
    Date Received
    July 22, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 23, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT PROVIDE THE LOT NUMBER, THEREFORE THE EXPIRATION DATE IS UNK. THE FACILITY DID NOT PROVIDE THE LOT NUMBER, THEREFORE THE MANUFACTURE DATE IS UNK. SORIN GROUP (B)(4) REC'D A REPORT THAT, TWO HRS INTO BYPASS, THE 1/2" BOOT SPLIT RESULTING IN A BLOOD LEAK. THE PIECE OF TUBING WAS REPLACED AND THE CASE CONTINUED. TWO MORE HRS INTO THE CASE, THE 1/2" TUBING SPLIT AGAIN CAUSING BLOOD LOSS. THE CASE WAS FINISHED W/O FURTHER ISSUES. THE TOTAL BLOOD LOSS FROM THE PT WAS ONE LITER AND THE PT WAS GIVEN ONE UNIT OF PACKED CELLS. THERE WAS NO REPORT OF PT INJURY. THE PRODUCT WAS RETURNED TO SORIN GROUP (B)(4) FOR EVAL. SORIN GROUP IS CONDUCTING AN INVESTIGATION. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. SECTION 5, BLOOD CARDIOPLEGIA, IN THE PUMP INSTRUCTIONS FOR USE STATE "¿INCORRECT TUBING CLAMP INSERTS CAN RESULT IN SEVERE FAILURES DURING PERFUSION SINCE THE TUBING IS EITHER PINCHED OR NOT SEATED SECURELY IN THE PUMP¿.CHECK IF THE TUBINGS LIE EVENLY ALONG THE PUMP RACEWAY. THE TUBINGS SHOULD NEITHER BE TWISTED, CROSSED OR KINKED¿BOTH TUBINGS MUST LIKE EVENLY W/O KINKS OR TWISTS ALONG THE PUMP RACEWAY, MUST NOT BE KINKED OR CROSSED, MUST BE TIGHTLY SECURED IN THE TUBING CLAMP INSERTS AND MUST NOT HAVE ANY PLAY WITHIN THE PUMP¿.THE CORRECT ADJUSTMENT OF THE PUMP OCCLUSION IS AN ESSENTIAL PRECONDITION." THE SORIN GROUP HEART LUNG INSTRUCTIONS FOR USE INCLUDED IN THE HEART LUNG PACK STATE THAT FAILURE TO MAINTAIN PROPER OCCLUSION OF THE ROLLER PUMP CAN LEAD TO PREMATURE PUMP HEAD TUBING FAILURE, RESULTING IN LEAKS. THE IFU STATES TO USE APPROPRIATE TUBING INSERTS AND TO MAINTAIN THE NATURAL CURVATURE OF THE TUBING WHEN PLACING IT IN THE RACEWAY. FAILURE TO PROPERLY INSTALL THE PUMP TUBING MAY RESULT IN DAMAGING THE TUBING.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) REC'D A REPORT THAT, TWO HRS INTO BYPASS, THE 1/2" BOOT SPLIT RESULTING IN A BLOOD LEAK. THE PIECE OF TUBING WAS REPLACED AND THE CASE CONTINUED. TWO MORE HRS INTO THE CASE, 1/2" TUBING SPLIT AGAIN CAUSING BLOOD LOSS. THE CASE WAS FINISHED W/O FURTHER ISSUES. THE TOTAL BLOOD LOSS FROM THE PT WAS ONE LITER AND THE PT WAS GIVEN ONE UNIT OF PACKED CELLS. THERE WERE NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC MIDWEST REG LXNGTN KY 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1