BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 ROLLER PUMP

    MDR report key: 1674156 · Received April 22, 2010

    Report

    Report Number
    1718850-2010-00024
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    August 5, 2008
    Report Date
    August 14, 2008
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. 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). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. THE FIELD SERVICE REPRESENTATIVE TESTED THE PUMP, BUT COULD NOT REPRODUCE THE PROBLEM. THE PUMP WAS SENT TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. VISUAL INSPECTION SHOWED CRACKS AND MECHANICAL DAMAGE ON THE CONTROL PANEL. THE CLAMPING MECHANISM WAS JAMMED. THE PUMP WAS TESTED FOR A DURATION OF 48 HRS IN A CONTINUOUS RUN MODE. NO FAILURE WAS DETECTED. THE PUMP WAS TESTED FOR APPROXIMATELY 360 HOURS AT DIFFERENT OCCLUSION SETTINGS. NO FAILURE WAS DETECTED. NO FAILURE WAS DETECTED DURING THE EXAMINATION OF THE CIRCUIT BOARDS AND THE WIRING HARNESS. DISASSEMBLY OF THE PUMP DRIVE REVEALED THAT THE CIRCUIT BOARD WAS NOT MOUNTED CORRECTLY. A SPACING BOLT WAS NOT SCREWED ON PROPERLY, THE MALE THREAD WAS MISSING. SORIN GROUP (B)(4) CONCLUDED THAT THE BOLT MUST HAVE BEEN MOUNTED INCORRECTLY WHEN THE MOTOR WAS REPLACED DURING A SCHEDULED MAINTENANCE. THE SENSOR, LOCATED ON THE CIRCUIT BOARD, SHOWED MECHANICAL WEAR CAUSED BY THE IMPULSE WHEEL ATTACHED TO THE MOTOR SHAFT. SORIN GROUP (B)(4) STATED THAT AS A RESULT OF THE INCORRECT MOUNTING OF THE CIRCUIT BOARD, THE IMPULSE WHEEL HAD MECHANICAL CONTACT WITH THE SENSOR, TRIGGERING THE REPORTED FAILURE AND PUMP STOPPAGE.

    Description of Event or Problem · 1

    AT THE BEGINNING OF ECC, THE ARTERIAL PUMP BLOOD FLOW RATE WAS ABNORMALLY SLOW. THE PUMP STOPPED SHOWING AN ALARM INDICATOR ERROR OF 010000. EFFORTS TO RESTART THE PUMP WERE UNSUCCESSFUL. THERE WAS NO REPORT OF PT INJURY.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1