BEUDAMED
    FDA Adverse Event Other Summary report: N

    WV UNIV HSP MORGANTOWN WV 1

    MDR report key: 2354881 · Received November 10, 2011

    Report

    Report Number
    1718850-2011-00210
    Event Type
    Other
    Date Received
    November 10, 2011
    Date of Event
    October 12, 2011
    Report Date
    October 12, 2011
    Manufacturer
    SORIN GROUP USA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR WHICH IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE 510(K) NUMBER FOR THE PRIMO2X OXYGENATOR IS K050447. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVOLVED OXYGENATOR WAS RETURNED TO SORIN FOR EVAL. UPON RECEIPT, THE UNIT WAS SUBJECTED TO LEAK AND SIMULATED USE TESTING. THE LEAK REPORTED BY THE CUSTOMER COULD NOT BE REPRODUCED DURING ANY OF THE INITIAL TESTING. THE OXYGENATOR HAS BEEN FORWARDED TO SORIN GROUP (B)(4) FOR FURTHER EVAL. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A COMPLAINT REPORTING THAT THE PERFUSIONIST NOTED A PINK TINGE IN THE WATER LINES DURING THE CASE. BLOODY FLUID WAS SEEN COMING FROM THE HEAT EXCHANGER WATER PORTS AFTER THE WATER LINES WERE DISCONNECTED FROM THE OXYGENATOR. THE UNIT WAS CHANGED OUT IN ORDER TO COMPLETE THE CASE. THE REPORT STATED THAT THE PT WAS FINE. NO ISSUES OCCURRED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WV UNIV HSP MORGANTOWN WV 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA NA 1125000042

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR