BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 STOCKERT CENTRIFUGAL PUMP SYSTEM

    MDR report key: 2181524 · Received July 15, 2011

    Report

    Report Number
    1718850-2011-00083
    Event Type
    Other
    Date Received
    July 15, 2011
    Date of Event
    April 7, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP. THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT OF A SQUEALING NOISE FROM THE REVOLUTION PUMP HEAD AND PUMP DRIVER, WHICH RESULTED IN LOW FLOW. THE PUMP DRIVER WAS MANUALLY CRANKED TO WEAN THE PT FROM BYPASS, THEN THE PUMP HEAD WAS RESEATED INTO THE PUMP DRIVER AND THE CASE CONTINUED. THERE WAS NO REPORT OF PT INJURY. HOWEVER, FURTHER COMMUNICATION WITH THE PERFUSIONIST REVEALED THAT SUB-OPTIMAL HAND CRANKING WAS NOT ABLE TO GENERATE SUFFICIENT FLOW FOR APPROXIMATELY 4 MIN BEFORE ASSISTANCE WAS PROVIDED. THE SCP CENTRIFUGAL PUMP WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. UPON RECEIPT, THE UNIT WAS SUBJECTED TO SIMULATED USE TESTING FOR APPROXIMATELY 12 HOURS AT HIGH AND LOW SPEED, WITH AND WITHOUT BACKPRESSURE. DURING INITIAL SIMULATED USE TESTING, THE PROBLEM WAS NOT DUPLICATED; THE DEVICE SUCCESSFULLY COMPLETED FUNCTIONAL TESTING. THE SCP PUMP PERFORMED AS EXPECTED. THE FLOW RATE WAS MAINTAINED AND NO ABNORMAL NOISE WAS PRODUCED AT ANY POINT THROUGH THE DURATION OF TESTING. THE REPORT OF HEARING A SQUEALING NOISE AND NOTICING THE FLOWS DROPPING OFF COULD NOT BE REPRODUCED AND THE CAUSE FOR THE CLINICIANS CONCERN COULD NOT BE DETERMINED. NO STRUCTURAL OR PERFORMANCE DEFECTS WERE FOUND. THE SCP PUMP HAS BEEN SENT TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. THE INVESTIGATION IS ON GOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE AND RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF A SQUEALING NOISE FROM THE REVOLUTION PUMP HEAD AND PUMP DRIVER, WHICH RESULTED IN LOW FLOW. THE PUMP DRIVER WAS MANUALLY CRANKED TO WEAN THE PT FROM BYPASS, THEN THE PUMP HEAD WAS RESEATED INTO THE PUMP DRIVER AND THE CASE CONTINUED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 STOCKERT CENTRIFUGAL PUMP SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DWA SORIN GROUP DEUTSCHLAND 60-00-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1