BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2925251 · Received January 11, 2013

    Report

    Report Number
    1718850-2012-01128
    Event Type
    Other
    Date Received
    January 11, 2013
    Date of Event
    October 7, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SORIN GORUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. 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). SORIN GROUP RECEIVED A REPORT THAT A CUSTOMER EXPERIENCED A PROBLEM WITH THE TOUCH SCREEN OF THE S5 ROLLER PUMP. 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 A CUSTOMER EXPERIENCED A PROBLEM WITH THE TOUCH SCREEN OF THE S5 ROLLER PUMP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17931 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GORUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1