BEUDAMED
    FDA Adverse Event Other Summary report: N

    D731 MICRO 27 PH.I.S.O. ARTERIAL FILTER

    MDR report key: 3894229 · Received June 16, 2014

    Report

    Report Number
    1718850-2014-00199
    Event Type
    Other
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTM
    PMA / PMN Number
    K112525
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE D731 MICRO 27 PH.I.S.I.O. ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE OUTLET PORT OF THE ARTERIAL LIFE WAS FOUND BROKEN OFF DURING THE SET UP OF THE PACK. A NEW ARTERIAL FILTER ASSEMBLY WAS SCAVENGED FROM A PACK OFF OF THE SHELF IN ORDER TO BE ABLE TO USE THIS HEART LUNG PACK. THERE WAS NO PT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE OUTLET PORT OF THE ARTERIAL FILTER WAS FOUND BROKEN OFF DURING THE SET UP OF THE PACK. A NEW ARTERIAL FILTER ASSEMBLY WAS SCAVENGED FROM A PACK OFF OF THE SHELF IN ORDER TO BE ABLE TO USE THIS HEART LUNG PACK. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353123 D731 MICRO 27 PH.I.S.O. ARTERIAL FILTER FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM SORIN GROUP ITALIA NA 1401210072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA