BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PU,P

    MDR report key: 5001368 · Received August 8, 2015

    Report

    Report Number
    9611109-2015-00287
    Event Type
    Malfunction
    Date Received
    August 8, 2015
    Date of Event
    July 9, 2015
    Report Date
    March 23, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE EVENT OCCURRED IN (B)(6).(B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE TESTED THE DEVICE AND WAS UNABLE TO REPRODUCE THE REPORTED MALFUNCTION. VISUAL INSPECTION IDENTIFIED BUILD UP ON THE GASKET OF THE TOUCH SCREEN THAT COULD BE CAUSED BY CLEANING THE SCREEN WITH WIPES. THE SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO CLEAN THE TOUCH SCREEN WITH A DRY CLOTH ONLY. AS A PRECAUTION, THE TOUCH SCREEN WAS REPLACED. AFTER SERVICE, IT WAS CONFIRMED BY THE PERFUSIONIST THAT THE SYSTEM WORKED WITHIN SPECIFICATIONS. THE CUSTOMER KEPT THE OLD TOUCH SCREEN. NO FURTHER ISSUES HAVE BEEN REPORTED FOR THIS UNIT. AS THE ISSUE WAS NOT REPRODUCED AND THE CUSTOMER KEPT THE REPLACED TOUCH SCREEN, A ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. DEVICE EVALUATED ON SITE BY LIVANOVA TECHNICIAN.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE PUMP TOUCHSCREEN WAS UNRESPONSIVE DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521403 S5 ROLLER PU,P CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP