BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 DOUBLE HEAD PUMP

    MDR report key: 3143234 · Received May 30, 2013

    Report

    Report Number
    1718850-2013-00086
    Event Type
    Other
    Date Received
    May 30, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K955038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 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 AT THE START OF BYPASS, PRIOR TO CROSS CLAMP, THE CLINICIAN TURNED THE SPEED KNOB OF THE S3 DOUBLE HEAD PUMP AND THE PUMP DID NOT TURN. AFTER SEVERAL SECONDS AN ERROR MESSAGE WAS DISPLAYED. THE CUSTOMER STATED THAT THE ERROR COULD NOT BE CLEARED BY POWER CYCLING THE PUMP UNLESS THE SPEED KNOB WAS RETURNED TO THE ZERO POSITION. THE PUMP WAS CHANGED OUT IN APPROXIMATELY TWO MINUTES. THERE WAS NO REPORT OF PT INJURY. A SORIN SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO EVALUATE THE ISSUE. THE REPRESENTATIVE COMPLETELY DISASSEMBLED THE PUMP, CHECKED ALL CONNECTIONS AND CABLES, REMOVED THE CARD CAGE AND CONTROL BOARDS, AND REASSEMBLED THE PUMP. THE PROBLEM COULD NOT BE REPRODUCED. THE PUMP WAS RUN FOR APPROXIMATELY 50 CYCLES WITH NO FAILURES OR ABNORMALITIES. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT AT THE START OF BYPASS, PRIOR TO CROSS CLAMP, THE CLINICIAN TURNED THE SPEED KNOB OF THE S3 DOUBLE HEAD PUMP AND THE PUMP DID NOT TURN. AFTER SEVERAL SECONDS AN ERROR MESSAGE WAS DISPLAYED. THE CUSTOMER STATED THAT THE ERROR COULD NOT BE CLEARED BY POWER CYCLING THE PUMP UNLESS THE SPEED KNOB WAS RETURNED TO THE ZERO POSITION. THE PUMP WAS CHANGED OUT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239299 S3 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-65-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR