BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 DOUBLE HEAD PUMP

    MDR report key: 2860257 · Received November 29, 2012

    Report

    Report Number
    1718850-2012-01102
    Event Type
    Other
    Date Received
    November 29, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K955038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. 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 SETUP FOR A CASE, THE S3 DOUBLE HEAD PUMP DISPLAYED AN ERROR MESSAGE AND STOPPED. THE CLINICIAN CHANGED OUT THE PUMP PRIOR TO THE PROCEDURE. THERE WAS NO PT INVOLVEMENT. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO EVALUATE THE ISSUE. THE SERVICE REPRESENTATIVE TESTED THE PUMP AND FOUND A BAD CONNECTION IN THE PUMP PANEL. WHEN THE CONNECTION WAS PHYSICALLY MANIPULATED, THE REPORTED ERROR COULD BE REPRODUCED. THE SERVICE TECHNICIAN REPLACED THE PANEL AND ALL SUBSEQUENT TESTING FOUND THE PUMP TO BE WORKING PROPERLY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING SETUP FOR A CASE, THE S3 DOUBLE HEAD PUMP DISPLAYED AN ERROR MESSAGE AND STOPPED. THE CLINICIAN CHANGED OUT THE PUMP PRIOR TO THE PROCEDURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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