BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 2912831 · Received December 3, 2012

    Report

    Report Number
    1718850-2012-01078
    Event Type
    Other
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 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
    UK
    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 THE (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING SET-UP, THE TOUCH SCREEN FOR THE S5 DOUBLE HEAD PUMP WAS UNRESPONSIVE. THE TOUCH SCREEN OF THE PUMP WAS REPLACED. THERE WAS NO PT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING SET-UP, THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS UNRESPONSIVE. THE TOUCH SCREEN OF THE PUMP WAS REPLACED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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