BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONSOLE FOR 4 PUMP

    MDR report key: 6183262 · Received December 16, 2016

    Report

    Report Number
    9611109-2016-00955
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE LEARNED THAT THE CUSTOMER WAS ORIGINALLY HAVING PROBLEMS WHEN TRYING TO ACCESS THE SERVICE MENU. THE SERVICE REPRESENTATIVE EVALUATED THE DEVICE AND WAS UNABLE TO ACTIVATE OR DEACTIVATE ANY OF THE ICONS ON THE DISPLAY; THE TOUCHSCREEN WAS COMPLETELY UNRESPONSIVE. THE TOUCHSCREEN WAS REPLACED TO RESOLVE THE ISSUE. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    LIVANOVA(B)(4) PERFORMED A VISUAL INSPECTION IN HOUSE ON THE RETURNED PART AND COULD CONFIRM THE FAILURE. FLUID HAD PENETRATED INTO THE CAPTON TAIL, WHICH COULD HAVE CAUSED OXIDATION. ROOT CAUSE FLUID/MOISTURE INGRESS WAS DETERMINED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE SORIN CENTRIFUGAL PUMP 5 (CP5) DID NOT WORK POST PROCEDURALLY. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 1

    CP5 TOUCHSCREEN NOT WORKING. CUSTOMER COMPLAIN THAT THEY ARE UNABLE TO GO INTO THE SERVICE MENU. 97-103-617 LED DISPLAY W. TOUCHSCREEN S5. 96-231-043 RIBBON CABLE 33-L. X TFT-DISPL. 96-231-045 FLAT RIBBON CABLE P06. SERVICE CONFIRMATION: 9000021380, FROZEN CP5 TOUCHSCREEN. SRD S5 CONSOLE FOR 4 PUMP 48E03146. CP5 TOUCHSCREEN NOT WORKING. CP5 TOUCHSCREEN NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834227 S5 CONSOLE FOR 4 PUMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND 48-40-00

    Patients

    Seq Age Sex Outcome Treatment
    1