BEUDAMED
    FDA Adverse Event Summary report: N

    S3 ROLLER PUMP

    MDR report key: 6024840 · Received October 12, 2016

    Report

    Report Number
    9611109-2016-00652
    Date Received
    October 12, 2016
    Date of Event
    September 14, 2016
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K950990
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER PROVIDED IN THE INITIAL REPORT, SUBMITTED OCTOBER 12, 2016, WAS INCORRECT. THE CORRECT 510(K) NUMBER IS K950990.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S3 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S3 ROLLER PUMP DID NOT CIRCULATE FOLLOWING AN ERROR MESSAGE THAT THE USER RECEIVED DURING SETUP. THE POWER WAS CYCLED OFF AND ON, BUT THE PUMP DID NOT ROTATE. THERE WAS NO PATIENT INVOLVEMENT. A SORIN GROUP FIELD SERVICE REPRESENTATIVE TESTED THE UNIT AND WAS ABLE TO CONFIRM THE REPORTED ISSUE. THE SERVICE REPRESENTATIVE IDENTIFIED A DEFECTIVE COMPONENT ON THE MOTOR CONTROL PCB. THE BOARD WAS REPLACED TO RESOLVE THE ISSUE. THE SERVICE REPRESENTATIVE WAS UNABLE TO REPRODUCE THE ERROR FOLLOWING THE REPLACEMENT. PHOTOS WERE PROVIDED TO SORIN GROUP (B)(4) AND THE ISSUE WAS CONFIRMED. AFTER FURTHER COMMUNICATION WITH THE CUSTOMER, SORIN GROUP (B)(4) LEARNED THAT THE PUMP DISPLAYED AN ERROR CODE AFTER TURNING ON OF THE PUMP. THE USER DID NOT NOTICE THE ERROR CODE AND CONTINUED OPERATING THE PUMP, WHICH LED TO THE REPORTED FAILURE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. NO TREND WAS IDENTIFIED FOR THIS TYPE OF ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S3 ROLLER PUMP DID NOT CIRCULATE FOLLOWING AN ERROR MESSAGE THAT THE USER RECEIVED DURING SETUP. THE POWER WAS CYCLED OFF AND ON, BUT THE PUMP DID NOT ROTATE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673527 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-60-00

    Patients

    Seq Age Sex Outcome Treatment
    1