BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV OF CHARLOTTESVILLE VA1

    MDR report key: 2108728 · Received April 21, 2011

    Report

    Report Number
    1718850-2011-00030
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE FILED IF THIS INFO IS RECEIVED. SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR AND THE 510(K) NUMBER IS K050447. THE OXYGENATOR IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE INCIDENT OCCURRED AT THE (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE PERFUSIONIST REPORTED THAT WHEN THE HEATER COOLER WATER LINE CLAMP WAS REMOVED, BLOOD WAS SEEN COMING FROM THE HEAT EXCHANGER OUTLET OF THE PRIMO2 OXYGENATOR. THE PRIMO2X OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR EVAL. VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS. PRESSURE DECAY AND SIMULATED USE 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 (B)(4) FOR FURTHER EVAL. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT WHEN THE HEATER COOLER WATER LINE CLAMP WAS REMOVED, BLOOD WAS SEEN COMING FROM THE HEAT EXCHANGER OUTLET OF THE PRIMO2X OXYGENATOR. THE UNIT WAS CHANGED OUT WITHIN ONE MINUTE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIV OF CHARLOTTESVILLE VA1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 1004200030

    Patients

    Seq Age Sex Outcome Treatment
    1