BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 3252484 · Received July 24, 2013

    Report

    Report Number
    1718850-2013-00133
    Event Type
    Other
    Date Received
    July 24, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD REP WAS DISPATCHED TO INVESTIGATE. WHILE AT THE FACILITY, THE FIELD SERVICE REP WAS ABLE TO REPRODUCE THE ERROR SO THE MOTOR CONTROL BOARD WAS REPLACED AND SUBSEQUENT TESTING CONFIRMED THAT THE ISSUE WAS RESOLVED. 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 S5 ROLLER PUMP WHICH WAS BEING USED A SUCKER PUMP DISPLAYED AN ERROR MESSAGE DURING THE PROCEDURE. THE CLINICIAN MOVED THE SUCKER TUBING TO ANOTHER PUMP AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344424 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP