BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEVELAND CLINIC CLEVELAND OH1

    MDR report key: 2538470 · Received April 6, 2012

    Report

    Report Number
    1718850-2012-00035
    Event Type
    Other
    Date Received
    April 6, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 9, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TUBING IN THE PUMP RACEWAY DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE ISSUE. SORIN GROUP HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR EVALUATION. TO DATE, NO PRODUCT HAS BEEN RECEIVED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TUBING IN THE PUMP RACEWAY SPLIT DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEVELAND CLINIC CLEVELAND OH1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 1119400007

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR