BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 2923254 · Received January 9, 2013

    Report

    Report Number
    1718850-2012-01113
    Event Type
    Other
    Date Received
    January 9, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED 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 DOUBLE HEAD PUMP DID NOT WORK PROPERLY DURING PRIMING. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11044 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