BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 4202621 · Received October 16, 2014

    Report

    Report Number
    1718850-2014-00369
    Event Type
    Other
    Date Received
    October 16, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 17, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    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 INVOLVEMENT. SORIN GROUP (B)(4) MFRS THE S5 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 SETUP THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS UNRESPONSIVE. THERE WAS NO PT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING SETUP THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT. NO PRODUCT WAS RETURNED FOR EVALUATION. BASED ON PHOTOGRAPHS OF THE INVOLVED DEVICE, SORIN GROUP (B)(4) HAS CONCLUDED THAT THE ISSUE WAS CAUSED BY LIQUID HAVING PENETRATED INTO THE TOUCH SCREEN. A CAPA WAS INITIATED AND A CHANGE ORDER HAS BEEN IMPLEMENTED WITH CORRECTIVE ACTIONS TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING SETUP THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS UNRESPONSIVE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659896 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-85-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA