BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 4863446 · Received June 17, 2015

    Report

    Report Number
    9611109-2015-00188
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 21, 2015
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE FLOW DISPLAY SHOWED DASHED LINES FOLLOWED BY AN ALARM AND THEN RETURNED TO NORMAL, CYCLING APPROXIMATELY EVERY THIRTY SECONDS. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED FAILURE AND THROUGH DETAILED TROUBLESHOOTING, THE FAILURE WAS TRACED TO A DEFECTIVE MOTOR CONTROL AND CPU BOARD. THE TWO BOARDS WERE REPLACED TO RESOLVE THE ISSUE AND SUBSEQUENT FUNCTIONAL TESTING DID NOT IDENTIFY FURTHER ISSUES. THE UNIT WAS RETURNED TO SERVICE. 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. EVALUATED ON-SITE BY SORIN SERVICE REP.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE FLOW DISPLAY SHOWED DASHED LINES FOLLOWED BY AN ALARM AND THEN RETURNED TO NORMAL, CYCLING APPROXIMATELY EVERY THIRTY SECONDS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392734 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTTOL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND GMBH 60-02-15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA