BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 1668376 · Received April 23, 2010

    Report

    Report Number
    1718850-2010-00033
    Event Type
    Other
    Date Received
    April 23, 2010
    Date of Event
    January 19, 2006
    Report Date
    January 23, 2006
    Manufacturer
    SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 ROLLER PUMP. THE 510(K) NUMBER IS K950990. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE SORIN SERVICE TECH WAS DISPATCHED TO EVALUATE THE PUMP ON SITE. HE COULD NOT REPRODUCE THE PROBLEM. THE PUMP WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. SORIN GROUP (B)(4) COULD NOT REPRODUCE THE PROBLEM. AS A PREVENTATIVE MEASURE, TWO CIRCUIT BOARDS WERE REPLACED. THE PUMP WAS THEN SUBJECTED TO FOUR DAYS OF TESTING. THE PUMP FUNCTIONED PROPERLY. SORIN GROUP (B)(4) COULD NOT RE-CREATE THE REPORTED PROBLEM. THE INSTRUCTION FOR USE DESCRIBE HOW TO SAFELY HAND CRANK THE PUMP TO START, CONTINUE OR CONCLUDE A PROCEDURE IN THE EVENT OF A PUMP STOPPAGE. (B)(4). THIS MEDWATCH REPORT IS FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ARTERIAL PUMP STOPPED. AN ERROR CODE 010040 WAS DISPLAYED. THE PERFUSIONIST HAND CRANKED TO MAINTAIN BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1