BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 5418317 · Received February 8, 2016

    Report

    Report Number
    9611109-2016-00025
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    January 18, 2016
    Report Date
    January 18, 2016
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE S5 DOUBLE HEAD PUMP BEING USED AS THE CARDIOPLEGIA PUMP DISPLAYED AN ERROR MESSAGE DURING PRIMING. THE ERROR WAS CLEARED BY RESTARTING THE UNIT, BUT WHEN THE PUMP ATTEMPTED TO DELIVER CARDIOPLEGIA, THE FLOW RATE DISPLAYED DASHES AND THE PUMP DID NOT RESPOND TO KNOB ROTATION. THERE WAS NO PATIENT 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) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE S5 DOUBLE HEAD PUMP BEING USED AS THE CARDIOPLEGIA PUMP DISPLAYED AN ERROR MESSAGE DURING PRIMING. THE ERROR WAS CLEARED BY RESTARTING THE UNIT, BUT WHEN THE PUMP ATTEMPTED TO DELIVER CARDIOPLEGIA, THE FLOW RATE DISPLAYED DASHES AND THE PUMP DID NOT RESPOND TO KNOB ROTATION. THERE WAS NO PATIENT INVOLVEMENT. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. A SERIAL READOUT WAS PERFORMED AND SENT TO SORIN GROUP (B)(4) FOR EVALUATION, WHERE IT WAS DETERMINED THAT THE HMF MOTOR ENDSTAGE BOARD WAS CAUSING THE ISSUE. THE HMF MOTOR ENDSTAGE BOARD WAS REMOVED FROM THE UNIT AND RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT IDENTIFY ANY ABNORMALITIES. THE BOARD WAS FUNCTIONALLY TESTED AND THE REPORTED ISSUE WAS REPRODUCED. A HARDWARE ANALYSIS FOUND NO 5V SUPPLY OUTPUT VOLTAGE AND A SHORT CIRCUIT BETWEEN THE INPUT AND OUTPUT VOLTAGES OF THE DC/DC CONVERTER. THE DC/DC CONVERTER WAS REPLACED AND SUBSEQUENT TESTS FOUND NO FURTHER ERRORS. THE DEVICE WAS RETURNED TO THE CUSTOMER. 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.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S5 DOUBLE HEAD PUMP BEING USED AS THE CARDIOPLEGIA PUMP DISPLAYED AN ERROR MESSAGE DURING PRIMING. THE ERROR WAS CLEARED BY RESTARTING THE UNIT, BUT WHEN THE PUMP ATTEMPTED TO DELIVER CARDIOPLEGIA, THE FLOW RATE DISPLAYED DASHES AND THE PUMP DID NOT RESPOND TO KNOB ROTATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74381 S5 DOUBLE HEAD PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE DWB SORIN GROUP DEUTSCHLAND 10-85-00 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1