BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 5142597 · Received October 10, 2015

    Report

    Report Number
    9611109-2015-00393
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    September 7, 2015
    Report Date
    March 20, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE S5 DOUBLE HEAD PUMP SHOWED A GRAPHIC DISPLAY FAILURE MESSAGE, AND LATER WHEN THE DEVICE WAS TURNED ON THE DISPLAY WENT DARK. THIS INCIDENT OCCURRED DURING SET-UP, SO THERE WAS NO PATIENT INVOLVEMENT. 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 DOUBLE 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 WAS ABLE TO REPRODUCE THE FAULT. THE DEFECTIVE LCD SCREEN AND THE HKR BOARD WERE REPLACED. THE UNIT WAS FUNCTIONALLY TESTED WITHOUT ISSUE AND RETURNED TO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED FOR THIS UNIT. AN EXACT ROOT CAUSE WAS NOT DETERMINED. HOWEVER, A DEFECTIVE INTERNAL ELECTRONIC COMPONENT IS THE MOST LIKELY ROOT CAUSE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. EVALUATED ON SITE BY LIVANOVA TECHNICIAN.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE S5 DOUBLE HEAD PUMP SHOWED A GRAPHIC DISPLAY FAILURE MESSAGE, AND LATER WHEN THE DEVICE WAS TURNED ON THE DISPLAY WENT DARK. THIS INCIDENT OCCURRED DURING SET-UP, SO THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673999 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-85-00 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR