BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV OF VA CHARLOTTESVILLE VA1

    MDR report key: 1628295 · Received March 1, 2010

    Report

    Report Number
    1718850-2010-00015
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 2, 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 LOT NUMBER WAS NOT PROVIDED. THEREFORE, NO EXPIRATION DATE IS AVAILABLE. G5 - 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. H4 - THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, NO MANUFACTURING DATE IS AVAILABLE. ONE PRIMO2X OXYGENATOR WAS RETURNED TO SORIN GROUP USA, INC 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 OXYGENATOR WAS RETURNED TO SORIN GROUP ITALIA FOR FURTHER EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WITH SORIN GROUP (B)(4) FINDINGS.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT WHEN HE OPENED THE CLAMP ON THE WATER LINES AND STARTED TO RECIRCULATE TO REWARM THE PATIENT, A SHOT OF RED CAME OUT OF THE OXYGENATOR. THE PERFUSIONIST QUICKLY CLAMPED THE WATER LINE. HE AGAIN UNCLAMPED THE LINE AND A RED SHOT WAS SEEN. THE OXYGENATOR WAS CHANGED OUT TO COMPLETE THE CASE. THERE WAS NO REPORT OF PATIENT INJURY.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1