BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP CONSOLE

    MDR report key: 4202620 · Received October 15, 2014

    Report

    Report Number
    1718850-2014-00374
    Event Type
    Other
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    KFM
    PMA / PMN Number
    K020571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURES THE SCPC SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THERE WAS AN OUT OF BOX FAILURE OF THE TOUCH SCREEN OF THE SCPC CENTRIFUGAL PUMP CONSOLE. AS A RESULT OF THE INVESTIGATION, A PROBLEM WITH THE TOUCH SCREEN WAS FOUND. DURING THE HARDWARE ANALYSIS IT WAS DETERMINED THAT THE POTENTIOMETER ON THE TOUCH PCB, WHICH IS RESPONSIBLE FOR BRIGHTNESS, WAS MISALIGNED. AFTER READJUSTMENT OF THE POTENTIOMETER AND RECALIBRATION OF THE TOUCH SCREEN, THE DISPLAY WORKED AS SPECIFIED. NO NONCONFORMITIES WERE NOTED DURING MANUFACTURING RECORD REVIEW. THE UNIT WILL BE SCRAPPED. THE ISSUE WILL BE MONITORED FOR TRENDS AND IF IDENTIFIED, CORRECTIONS WILL BE RECOMMENDED.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MFRS THE (PRODUCT). THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). 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 THERE WAS AN OUT OF BOX FAILURE OF THE TOUCH SCREEN OF THE SCPC CENTRIFUGAL PUMP CONSOLE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656262 STOCKERT CENTRIFUGAL PUMP CONSOLE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP DEUTSCHLAND 60-03-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA