BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHI GREENVILLE NC 2

    MDR report key: 2379491 · Received November 30, 2011

    Report

    Report Number
    1718850-2011-00237
    Event Type
    Other
    Date Received
    November 30, 2011
    Date of Event
    November 11, 2011
    Report Date
    November 11, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D733 ARTERIAL FILTER. THE 510(K) NUMBER IS K112525. THE ARTERIAL FILTER IS A COMPONENT OF THE CUSTOM PERFUSION PACK WHICH IS A PREAMENDMENT DEVICE. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT WHILE PRIMING, THE OUTLET PORT OF THE ARTERIAL FILTER BROKE OFF. THEY SCAVENGED A NEW FILTER ASSEMBLY FROM A PACK OFF THE SHELF. THERE WAS NO PT INVOLVEMENT. THE ARTERIAL FILTER WAS RETURNED TO FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT WHILE PRIMING, THE OUTLET PORT OF THE ARTERIAL FILTER BROKE OFF. THEY SCAVENGED A NEW FILTER ASSEMBLY FROM A PACK OFF THE SHELF. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHI GREENVILLE NC 2 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 1119400043

    Patients

    Seq Age Sex Outcome Treatment
    1