BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 6054310 · Received October 25, 2016

    Report

    Report Number
    9611109-2016-00704
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 29, 2016
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4) (B)(6) . SORIN GROUP RECEIVED A REPORT THAT TOUCH SCREEN OF THE S5 ROLLER PUMP BECAME UNRESPONSIVE DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE CONFIRMED THE REPORTED ISSUE AND REPLACED THE TOUCH SCREEN AND HKD BOARD TO RESOLVE THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT TOUCH SCREEN OF THE S5 ROLLER PUMP BECAME UNRESPONSIVE DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705304 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1