BEUDAMED
    FDA Adverse Event Other Summary report: N

    CP87312 DE FULDA

    MDR report key: 2482489 · Received February 29, 2012

    Report

    Report Number
    1718850-2012-00013
    Event Type
    Other
    Date Received
    February 29, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE COMPACTFLO EVO OXYGENATOR WHICH IS A COMPONENT OF THE (B)(6) CUSTOM PERFUSION PACK. NEITHER THE CUSTOM PERFUSION PACK NOR THE EVO OXYGENATOR ARE SOLD IN THE UNITED STATES. HOWEVER, THE OXYGENATOR HEAT EXCHANGER IS THE SAME AS USED IN OTHER SORIN OXYGENATORS DISTRIBUTED IN THE UNITED STATES. THEREFORE, THERE IS NO 510(K) NUMBER FOR THIS OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT AFTER SETTING UP AND PRIMING THE CIRCUIT, THE PRIMING SOLUTION DRIPPED OUT OF THE INLET AND OUTLET WASTER PORTS OF THE OXYGENATOR HEAT EXCHANGER. THIS OCCURRED DURING SET UP. THERE WAS NO PT INVOLVEMENT. SORIN GROUP (B)(4) HAS REQUESTED THE PRODUCT BE RETURNED FOR EVAL. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT AFTER SETTING UP AND PRIMING THE CIRCUIT, THE PRIMING SOLUTION DRIPPED OUT OF THE INLET AND OUTLET WATER PORTS OF THE OXYGENATOR HEAT EXCHANGER. THIS OCCURRED DURING SET-UP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP87312 DE FULDA CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1109270078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA