BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 3109346 · Received May 8, 2013

    Report

    Report Number
    1718850-2013-00069
    Event Type
    Other
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    PMA / PMN Number
    K934847
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). IT WAS ALSO REPORTED THAT EVAL PERFORMED BY THE CLINICIAN SUGGESTED THE ISSUE MAY HAVE BEEN CAUSED BY COLD "AGGLUTINS." THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CORIN GROUP (B)(4) RECEIVED A REPORT THAT CLUMPING OF THE RED CELLS WAS SEEN IN THE TUBING OF THE SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM AFTER ADMINISTERING CARDIOPLEGIA. THE DEVICE WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200132 SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTN SORIN GROUP ITALIA NA 1209040056

    Patients

    Seq Age Sex Outcome Treatment
    1 NP