BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHI GREENVILLE NC 2

    MDR report key: 2357579 · Received November 22, 2011

    Report

    Report Number
    1718850-2011-00232
    Event Type
    Other
    Date Received
    November 22, 2011
    Date of Event
    October 25, 2011
    Report Date
    October 25, 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 CUSTOMER PERFUSION PACK. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP USA RECEIVED A REPORT THAT WHILE PRIMING, THE ARTERIAL FILTER OUTLET PORT AND THE ATTACHED TUBING BROKE OFF. THIS WAS FOUND AND CORRECTED PRIOR TO ANY PT INVOLVEMENT. THE ARTERIAL FILTER HAS BEEN RETURNED TO SORIN GROUP USA FOR FURTHER ANALYSIS. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT WHILE PRIMING, THE ARTERIAL FILTER OUTLET PORT AND THE ATTACHED TUBING BROKE OFF. THIS WAS FOUND AND CORRECTED PRIOR TO ANY 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 1115800046

    Patients

    Seq Age Sex Outcome Treatment
    1