BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 3982893 · Received July 9, 2014

    Report

    Report Number
    1718850-2014-00216
    Event Type
    Other
    Date Received
    July 9, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 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 THE S3 ROLLER PUMP WOULD NOT RESTART AFTER THE CLINICIAN HAD CLEARED A LEVEL ALARM DURING THE PROCEDURE. A SORIN SERVICE REPRESENTATIVE COULD NOT REPRODUCE THE REPORTED PROBLEM DURING THE EVALUATION OF THE DEVICE THE FLOW CONTROL DISPLAYED AN ERROR MESSAGE. THE SPEED POTENTIOMETER WAS REPLACED AND TESTING FOUND THE PUMP PERFORMED AS EXPECTED. THE SPEED POTENTIOMETER WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. DURING EVALUATION USING THE VOLTAGE METER, VOLTAGE LOSS WAS FOUND BUT THE REPORTED ISSUE WAS NOT CONFIRMED OR REPRODUCED. WITHOUT THE ABILITY TO REPRODUCE THE REPORTED ISSUE, THE ROOT CAUSE COULD NOT BE DETERMINED AND NO CORRECTIVE ACTIONS COULD BE IDENTIFIED. SORIN GROUP DEUTSCHLAND DETERMINED THAT NO FURTHER INVESTIGATION IS REQUIRED, AS THE PROBLEM COULD NOT BE REPRODUCED AND NO TREND HAS BEEN IDENTIFIED. NO NONCONFORMITIES WERE NOTED DURING MANUFACTURING RECORD REVIEW. THE ISSUE WILL BE MONITORED FOR TRENDS AND IF IDENTIFIED, CORRECTIONS WILL BE RECOMMENDED.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 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.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE S3 ROLLER PUMP WOULD NOT RESTART AFTER THE CLINICIAN HAD CLEARED A LEVEL ALARM DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402168 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-60-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP