BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 3952357 · Received July 15, 2014

    Report

    Report Number
    1718850-2014-00221
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    May 26, 2014
    Report Date
    March 8, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    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 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 REPRODUCED THE REPORTED ISSUE. THE FAULTY TOUCH SCREEN WAS REPLACED TO RESOLVE THE ISSUE. THE UNIT WAS TESTED WITHOUT ISSUE AND WAS RETURNED TO SERVICE. A PHOTOGRAPH OF THE KAPTON-TAIL DATE-CODE WAS PROVIDED TO LIVANOVA (B)(4) FOR REVIEW. ANALYSIS OF THE PHOTOGRAPH CONFIRMED AGING AND WEAR TO BE THE MOST LIKELY ROOT CAUSE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA (B)(4) INITIATED A ROOT CAUSE INVESTIGATION (B)(4) FOR THIS TYPE OF ISSUE. EVALUATED ON SITE BY LIVANOVA TECHNICIAN.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. 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). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 ROLLER PUMP WAS FOUND TO BE DEFECTIVE DURING INSTALLATION AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. 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 FOUND TO BE DEFECTIVE DURING INSTALLATION AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412976 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA