BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 MAST ROLLER PUMP

    MDR report key: 3071043 · Received April 12, 2013

    Report

    Report Number
    1718850-2013-00049
    Event Type
    Other
    Date Received
    April 12, 2013
    Date of Event
    February 20, 2012
    Report Date
    March 18, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K062396
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 MAST ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 MAST ROLLER PUMP WAS UNRESPONSIVE DURING SET U P. THERE WAS NO PT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 MAST ROLLER PUMP WAS UNRESPONSIVE DURING SET UP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157906 S5 MAST ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1