BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 4939968 · Received July 21, 2015

    Report

    Report Number
    9611109-2015-00267
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 23, 2015
    Report Date
    March 20, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED 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). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND REPLACED THE TOUCH SCREEN TO RESOLVE THE ISSUE. SUBSEQUENT FUNCTIONAL AND ELECTRICAL TESTING DID NOT IDENTIFY FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. NO FURTHER RECURRENCES HAVE BEEN REPORTED FOR THIS UNIT. A PHOTOGRAPH OF THE REPLACED SCREEN WAS SENT TO LIVANOVA (B)(4) FOR EVALUATION. IT WAS DETERMINED THAT THE ROOT CAUSE WAS FLUID INGRESS INTO THE TOUCH SCREEN. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA (B)(4) HAS IMPLEMENTED A CAPA (B)(4) FOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A SCHEDULED PREVENTATIVE MAINTENANCE THE ROLLER PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472052 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND GMBH 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA