BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEM HERMANN SW HOUSTON TX 1

    MDR report key: 2571762 · Received May 3, 2012

    Report

    Report Number
    1718850-2012-00044
    Event Type
    Other
    Date Received
    May 3, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 5, 2012
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    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 RECEIVED A REPORT THAT, DURING RE-WARMING, THE TUBING SLIPPED OFF OF THE RESERVOIR OUTLET REPORT. THE PERFUSIONIST IMMEDIATELY CLAMPED THE LINE AND RECONNECTED THE TUBING, MINIMIZING THE BLOOD LOSS. NO BLOOD PRODUCTS WERE GIVEN, NO MEDICAL INTERVENTION WAS REQUIRED AND THERE WAS NOT PT INJURY AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT DURING SET-UP, THE TUBING HAD BEEN SECURED TO THE PORT WITH A TIE BAND. THE RESERVOIR IN USE WAS NOT MANUFACTURED BY SORIN GROUP. THE TUBING FROM THE INVOLVED CUSTOMER PERFUSION PACK WAS RETURNED TO SORIN GROUP FOR EVAL. 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, DURING RE-WARMING, THE TUBING SLIPPED OFF OF THE RESERVOIR OUTLET REPORT. THE PERFUSIONIST IMMEDIATELY CLAMPED THE LINE AND RECONNECTED THE TUBING, MINIMIZING THE BLOOD LOSS. NO BLOOD PRODUCTS WERE GIVEN, NO MEDICAL INTERVENTION WAS REQUIRED AND THERE WAS NOT PT INJURY AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT DURING SET-UP, THE TUBING HAD BEEN SECURED TO THE PORT WITH A TIE BAND. THE RESERVOIR IN USE WAS NOT MANUFACTURED BY SORIN GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEM HERMANN SW HOUSTON TX 1 CUSTOM PERFUSION PACK DWF SORIN GROUP USA, INC. NA 1127800049

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR