BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV OF VA CHARLOTTESVILLE VA1

    MDR report key: 1650902 · Received March 29, 2010

    Report

    Report Number
    1718850-2010-00078
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER FOR THE PRIMO2X OXYGENATOR IS K050447. THE PRIMO2X IS MANUFACTURED BY SORIN GROUP (B)(4) AND IS A COMPONENT OF THE CUSTOM PERFUSION PACK MANUFACTURED BY SORIN GROUP USA, INC. THE CUSTOM PERFUSION PACK, CATALOG NUMBER 089104301, IS A PRE-AMENDMENT DEVICE. ONE PRIMO2X OXYGENATOR, MANUFACTURED BY SORIN GROUP (B)(4), WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. A VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS. TESTING OF THE DEVICE DID IDENTIFY A LEAK PATH BETWEEN THE BLOOD SIDE AND WATER SIDE OF THE HEAT EXCHANGER. THE DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. TESTING CONFIRMED THE LEAK. AUTOPSY REVEALED A HOLE BETWEEN TWO COMPARTMENTS OF THE HEAT EXCHANGER LOCATED IN THE FOLDS OF THE STAINLESS STEEL SHEET. MANUFACTURING RECORDS WERE REVIEWED AND THE DEVICE PASSED ALL IN-PROCESS TESTS. FROM THIS, SORIN GROUP (B)(4) DETERMINED THAT THE HOLE DEVELOPED AFTER RELEASE. ANY FURTHER INVESTIGATION REPORTS SUBMITTED TO SORIN GROUP USA WILL BE FORWARDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    TEN TO FIFTEEN MINUTES INTO THE PROCEDURE, THE PERFUSIONIST NOTED A PINK TINGE IN THE WATER LINE. THE INLET WAS CLAMPED AND THERE WAS NO FLOW THROUGH THE HEAT EXCHANGER. WATER HAD NOT BEEN CIRCULATED. THE OXYGENATOR WAS CHANGED OUT. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIV OF VA CHARLOTTESVILLE VA1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA 1002100040

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR