BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSC CHARLESTON SC 1

    MDR report key: 2516048 · Received March 28, 2012

    Report

    Report Number
    1718850-2012-00033
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE VANGUARD CARDIOPLEGIA DEVICE WHICH IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE 510(K) NUMBER FOR THE VANGUARD IS K021830. THE CUSTOM PERFUSION PACK IS A PREAMENDMENT DEVICE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, DURING THE PROCEDURE, BLOOD WAS SEEN LEAKING FROM THE TOP OF THE VANGUARD UNIT. WHEN THE PUMP WAS TURNED OFF, AIR WAS PULLED INTO THE DEVICE. THE PERFUSIONIST USED BONE WAX TO SEAL THE LEAK AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. IT WAS CONFIRMED THAT THE DEVICE WAS NOT CONNECTED TO THE PT. NO AIR REACHED THE PT. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE WHITE VENT CAP WAS REMOVED AND TAPED TO THE FRONT OF THE UNIT AND BONE WAX WAS PRESENT IN THE VALVE. LEAK TESTING UNDER POSITIVE PRESSURE DID NOT RESULT IN FLUID LEAKING FROM THE UNIT BUT WHEN A VACUUM WAS APPLIED, AIR WAS PULLED INTO THE DEVICE CONFIRMING AN ISSUE WITH THE VALVE. LEAK TESTING UNDER POSITIVE PRESSURE DID NOT RESULT IN FLUID LEAKING FROM THE UNIT BUT WHEN A VACUUM WAS APPLIED, AIR WAS PULLED INTO THE DEVICE CONFIRMING AN ISSUE WITH THE VALVE. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT, DURING THE PROCEDURE, BLOOD WAS SEEN LEAKING FROM THE TOP OF THE VANGUARD UNIT. WHEN THE PUMP WAS TURNED OFF, AIR WAS PULLED INTO THE DEVICE. THE PERFUSIONIST USED BONE WAX TO SEAL THE LEAK AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. IT WAS CONFIRMED THAT THE DEVICE WAS NOT CONNECTED TO THE PT. NO AIR REACHED THE PT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSC CHARLESTON SC 1 CUSTOM PERFUSION PACK DWF SORIN GROUP ITALIA NA 1130400057

    Patients

    Seq Age Sex Outcome Treatment
    1