BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 3131473 · Received May 10, 2013

    Report

    Report Number
    1718850-2013-00073
    Event Type
    Other
    Date Received
    May 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 DOUBLE HEAD 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 S5 DOUBLE HEAD PUMP DISPLAYED AN ERROR MESSAGE DURING PREVENTIVE MAINTENANCE. THERE WAS NO PT INVOLVEMENT. THE SORIN GROUP FIELD SERVICE REP PERFORMING THE MAINTENANCE REPLACED THE MOTOR CONTROLLER BOARD AND SUBSEQUENT TESTING CONFIRMED THAT THE ISSUE WAS RESOLVED. THE INVESTIGATION IS ON-GOING. A F/U 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 DOUBLE HEAD PUMP DISPLAYED AN ERROR MESSAGE DURING PREVENTIVE MAINTENANCE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209356 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-85-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA