BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 4340622 · Received December 5, 2014

    Report

    Report Number
    1718850-2014-00448
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    October 20, 2014
    Report Date
    May 2, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    KRI
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT 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 CONFIRM THE REPORTED ISSUE AND TRACED THE FAILURE TO A DEFECTIVE TOUCH SCREEN. THE TOUCH SCREEN WAS REPLACED TO RESOLVE THE ISSUE AND SUBSEQUENT TESTING FOUND THE UNIT TO BE WORKING ACCORDING THE SPECIFICATIONS. THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. A CORRECTIVE ACTION REGARDING THIS TYPE OF ISSUE WAS IMPLEMENTED IN 2013.

    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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786148 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS KRI SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA