BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 DOUBLE HEAD PUMP

    MDR report key: 3031941 · Received March 27, 2013

    Report

    Report Number
    1718850-2013-00047
    Event Type
    Other
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K955038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE S3 DOUBLE HEAD PUMP DISPLAYED AN ERROR MESSAGE. THE ERROR OCCURRED BETWEEN CARDIOPLEGIA DOSES WHILE THE PUMP WAS NOT RUNNING. THE CLINICIAN POWERED CYCLED THE PUMP TO CLEAR THE ERROR AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE S3 DOUBLE HEAD PUMP DISPLAYED AN ERROR MESSAGE. THE ERROR OCCURRED BETWEEN CARDIOPLEGIA DOSES WHILE THE PUMP WAS NOT RUNNING. THE CLINICIAN CYCLED THE PUMP TO CLEAR THE ERROR AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125421 S3 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-65-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1