BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 MAST ROLLER PUMP AND CONTROL PANEL MAST ROLLER PUMP

    MDR report key: 2121948 · Received June 2, 2011

    Report

    Report Number
    1718850-2011-00045
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 2, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K060053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 HEART LUNG MACHINE. THE CONTROL PANEL IS A COMPONENT OF THE SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) HAS RECEIVED THE PRODUCT FOR EVAL AND IS CURRENTLY CONDUCTING AN INVESTIGATION. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF PT INJURY. THE INSTRUCTIONS FOR USE DESCRIBE HOW TO SAFELY HAND CRANK THE PUMP TO START, CONTINUE OR CONCLUDE A PROCEDURE IN EVENT OF A PUMP STOPPAGE. THE FACILITY HAS FILED A REPORT WITH THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A PUMP STOPPED DURING THE PROCEDURE. THE PERFUSIONIST HAND CRANKED THE PUMP TO MAINTAIN BLOOD FLOW TO THE PT. THE CONTROL PANEL WAS CHANGED OUT AND THE CASE PROCEEDED WITHOUT ISSUE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 MAST ROLLER PUMP AND CONTROL PANEL MAST ROLLER PUMP HEART LUNG MACHINE DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1