BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST FRANCIS HSP TULSA OK 1

    MDR report key: 2912916 · Received December 18, 2012

    Report

    Report Number
    1718850-2012-01092
    Event Type
    Other
    Date Received
    December 18, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 20, 2012
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARDIOPULMONARY BYPASS BLOOD RESERVOIR IS A COMPONENT OF THE CUSTOM PERFUSION PACK THE 501(K) NUMBER OF THE BLOOD RESERVOIR IS K882414. SORIN GROUP RECEIVED A REPORT THAT ON THE FOURTH DAY OF AN ECMO PROCEDURE, THE CLINICIAN NOTICED AIR HAD ENTERED THE PERFUSION CIRCUIT THROUGH A HOLE IN THE BLOOD RESERVOIR. THE CLINICIAN STOPPED THE PUMP AND CLAMPED OFF THE PT UNTIL THE CIRCUIT WAS REMOVED. THERE WAS NO PT INJURY. THE PRODUCT WAS RETURNED TO SORIN GROUP USA FOR EVAL. THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT ON THE FOURTH DAY OF AN ECMO PROCEDURE, THE CLINICIAN NOTICED AIR HAD ENTERED THE PERFUSION CIRCUIT THROUGH A HOLE IN THE BLOOD RESERVOIR. THE CLINICIAN STOPPED THE PUMP AND CLAMPED OFF THE PT UNTIL THE CIRCUIT WAS REMOVED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST FRANCIS HSP TULSA OK 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 1208100068

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA