BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2912932 · Received December 20, 2012

    Report

    Report Number
    1718850-2012-01111
    Event Type
    Other
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILLED OUT 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 DEUTSCHLAND RECEIVED A REPORT THAT THE S5 ROLLER PUMP STOPPED AND DISPLAYED AN ERROR MESSAGE DURING THE PROCEDURE. HAND-CRANKING WAS USED TO MAINTAIN BLOOD FLOW UNTIL FUNCTION WAS REGAINED BY POWER CYCLING THE PUMP AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    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