BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOWA METH DES MOINES IA1

    MDR report key: 2037963 · Received March 7, 2011

    Report

    Report Number
    1718850-2011-00014
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 10, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS NOT BEEN PROVIDED. A FOLLOW-UP REPORT WILL BE FILED IF THIS INFORMATION IS RECEIVED. SORIN GROUP (B)(4) MANUFACTURES THE APEX OXYGENATOR AND THE 510(K) NUMBER IS K083021. THE OXYGENATOR IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). IT WAS REPORTED THAT AFTER INITIATING AN EMERGENCY BYPASS, THE PERFUSIONIST NOTICED BLOOD LEAKING FROM THE APEX OXYGENATOR. THE MEMBRANE WAS CHANGED OUT. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF PATIENT INJURY. THE FACILITY REPORTED THAT THERE WAS APPROXIMATELY 320 CC BLOOD LOSS AND THAT THE PATIENT RECEIVED TWO UNITS OF BLOOD DUE TO LOW HEMATOCRITS. ALTHOUGH IT WAS STATED THAT THE FACILITY WAS UNSURE IF THE LOW HEMATOCRITS WERE DUE TO THE BLOOD LOSS OR THE EMERGENCY CASE, THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INITIATING AN EMERGENCY BYPASS, THE PERFUSIONIST NOTICED BLOOD LEAKING FROM THE APEX OXYGENATOR. THE MEMBRANE WAS CHANGED OUT. BLOOD LOSS WAS APPROXIMATELY 320 CC. THE PATIENT WAS GIVEN TWO UNITS DUE TO LOW HEMATOCRITS. THE REPORT INDICTED THAT THE FACILITY WAS UNSURE IF THE LOW HEMATOCRITS WERE DUE TO THE BLOOD LOSS OR DUE TO THE EMERGENCY CASE. IT WAS REPORTED THAT THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOWA METH DES MOINES IA1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 1032100021

    Patients

    Seq Age Sex Outcome Treatment
    1