BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 4170575 · Received October 1, 2014

    Report

    Report Number
    1718850-2014-00394
    Event Type
    Other
    Date Received
    October 1, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 4, 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
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. 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.

    Additional Manufacturer Narrative · 1

    IT WAS STATED IN THE MANUFACTURER NARRATIVE THAT THE DEVICE WAS NOT RETURNED, AND "AN INVESTIGATION OF THE REPORTED ISSUE COULD BE PERFORMED." THIS IS INCORRECT. AN INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE SERIAL NUMBER WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL REPORT. THE SERIAL NUMBER IS (B)(4). THE INITIAL REPORT STATED THAT THE MANUFACTURE DATE WAS 01/2012. THE CORRECT MANUFACTURE DATE IS 12/16/2011. SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER 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 POST-OPERATIVELY, THE TOUCH SCREEN OF THE S5 ROLLER PUMP STOPPED FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT. THE TOUCHSCREEN WAS REPLACED TO RESOLVE THE REPORTED ISSUE. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPLACED PART, HOWEVER THESE ATTEMPTS WERE UNSUCCESSFUL. AS THE DEVICE WAS NOT RETURNED, AN INVESTIGATION OF THE REPORTED ISSUE COULD BE PERFORMED, A ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. SORIN GROUP (B)(4) HAS NOT HEARD ANY REPORT OF RECURRENCE FOLLOWING THE TOUCH SCREEN REPLACEMENT. THE COMPLAINT INVESTIGATION WAS CONCLUDED ON AUGUST 25, 2016. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE. DEVICE REQUESTED; NO RESPONSE RECEIVED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT POST-OPERATIVELY, THE TOUCH SCREEN OF THE S5 ROLLER PUMP STOPPED FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612079 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA