BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN C5 SYSTEM WITH MAST ROLLER PUMP

    MDR report key: 2591899 · Received May 21, 2012

    Report

    Report Number
    1718850-2012-00054
    Event Type
    Other
    Date Received
    May 21, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 25, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K103762
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 SYSTEM. THE DOUBLE ROLLER PUMP TOUCHSCREEN IS COMPONENT OF THE SYSTEM. THE 510(K) NUMBER FOR THE SYSTEM IS K103762. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCHSCREEN OF THE DOUBLE ROLLER PUMP PANEL WAS INTERMITTENTLY UNRESPONSIVE. THERE WAS NO REPORT OF PT INJURY. SORIN GROUP (B)(4) HAS REQUESTED THAT THE DEVICE BE RETURNED FOR EVAL. TO DATE NO PRODUCT HAS BEEN RETURNED. THE INVESTIGATION IS ONGOING A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCHSCREEN OF THE DOUBLE ROLLER PUMP PANEL WAS INTERMITTENTLY UNRESPONSIVE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORIN C5 SYSTEM WITH MAST ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 58-00-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1