BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2748701 · Received September 6, 2012

    Report

    Report Number
    1718850-2012-00964
    Event Type
    Other
    Date Received
    September 6, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 9, 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

    NO PT INVOLVEMENT REPORTED. SORIN GROUP (B)(4) MANUFACTURES THE S5 TOUCH SCREEN WHICH IS A COMPONENT OF THE S5 ROLLER PUMP. THE 510(K) NUMBER OF THE S5 ROLLER PUMP IS K071318. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING PRIMING FOR A CASE, THE TOUCH SCREEN OF THE S5 ROLLER PUMP WAS INTERMITTENTLY NOT WORKING. THE INCIDENT OCCURRED DURING PRIME, 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 PRIMING FOR A CASE, THE TOUCH SCREEN OF THE S5 ROLLER PUMP WAS INTERMITTENTLY NOT WORKING. THE INCIDENT OCCURRED DURING PRIME, THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1