BEUDAMED
    FDA Adverse Event Other Summary report: N

    D733 MICRO 40 PH. I.S.O. ARTERIAL FILTER

    MDR report key: 3736629 · Received April 1, 2014

    Report

    Report Number
    1718850-2014-00083
    Event Type
    Other
    Date Received
    April 1, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D733 MICRO 40 PH.I.S.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 D733 ARTERIAL FILTER BROKE OFF DURING PRIMING OF THE SORIN HL PACK. THE ARTERIAL FILTER, ALONG WITH THE RESPECTIVE SORIN HL PACK, WAS REPLACED PRIOR TO 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 D733 ARTERIAL FILTER BROKE OFF DURING PRIMING OF THE SORIN HL PACK. THE ARTERIAL FILTER, ALONG WITH THE RESPECTIVE SORIN HL PACK, WAS REPLACED PRIOR TO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196383 D733 MICRO 40 PH. I.S.O. ARTERIAL FILTER FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM SORIN GROUP ITALIA NA 1309250120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA