BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 4297518 · Received November 21, 2014

    Report

    Report Number
    1718850-2014-00434
    Event Type
    Other
    Date Received
    November 21, 2014
    Date of Event
    October 25, 2014
    Report Date
    October 26, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IDENTIFIER, ACTUAL AGE AND WEIGHT WERE NOT PROVIDED. 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 F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE SORIN SERVICE REPRESENTATIVE COULD NOT REPRODUCE THE REPORTED ISSUE. THE S5 SYSTEM WAS INSPECTED AND IT WAS FOUND THAT PRESSURE 1 AND 2 WERE SET AS THE ONLY EXTERNAL CONTROLS FOR THE PUMP. THE PRESSURES WERE TESTED AND ALL TESTED PROPERLY. CONNECTIONS WERE VERIFIED, THE SHP WAS INSPECTED INTERNALLY AND A TEST AND SAFETY INSPECTION WAS PERFORMED FINDING NO ISSUES. THE SERIAL READOUT SHOWED THE PUMP FUNCTIONED ACCORDING TO THE INTENDED USE. A PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE UNIT AT A LATER DATE AND NO ISSUES WERE FOUND. THE UNIT HAS BEEN RETURNED TO SERVICE. NO FURTHER PROBLEMS HAVE BEEN REPORTED. NO NONCONFORMITIES WERE NOTED DURING MANUFACTURING RECORD REVIEW. THE ISSUE WILL BE MONITORED FOR TRENDS AND IF IDENTIFIED, CORRECTIONS WILL BE RECOMMENDED.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE S5 ROLLER PUMP STOPPED TWICE DURING AN ECMO PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758550 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NEONATE