BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 MAST ROLLER PUMP

    MDR report key: 2253447 · Received September 9, 2011

    Report

    Report Number
    1718850-2011-00101
    Event Type
    Other
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 11, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATE WILL BE PROVIDED IN A F/U WHEN AVAILABLE. SORIN GROUP (B)(4) MFRS THE S3 MAST ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A COMPLAINT REPORTING THAT, DURING THE PROCEDURE, THE VENT PUMP STOPPED AND A 040000 ERROR CODE WAS DISPLAYED. THE ENGINEER POWER CYCLED THE PUMP BUT IT DID NOT REGAIN FUNCTION. THE CLINICIAN ELECTED TO COMPLETE THE OPERATION WITHOUT THE VENT PUMP. AFTERWARDS, THE ENGINEER STARTED THE PUMP, RAN IT FOR A PERIOD OF TIME AND THEN ANOTHER ERROR CODE WAS DISPLAYED, 08000, AND THE PUMP AGAIN STOPPED. THERE WAS NO REPORT OF INJURY TO THE PT OR ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS INCIDENT. SORIN GROUP (B)(4) HAS REQUESTED THAT THE PUMP BE RETURNED FOR EVAL. TO DATE NO PRODUCT HAS BEEN RECEIVED. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A COMPLAINT REPORTING THAT, DURING THE PROCEDURE, THE VENT PUMP STOPPED AND A 040000 ERROR CODE WAS DISPLAYED. THE ENGINEER POWER CYCLED THE PUMP BUT IT DID NOT REGAIN FUNCTION. THE CLINICIAN ELECTED TO COMPLETE THE OPERATION WITHOUT THE VENT PUMP. AFTERWARDS, THE ENGINEER STARTED THE PUMP, RAN IT FOR A PERIOD OF TIME AND THEN ANOTHER ERROR CODE WAS DISPLAYED, 08000, AND THE PUMP AGAIN STOPPED. THERE WAS NO REPORT OF INJURY TO THE PT OR ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 MAST ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 50-60-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1