BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 1674563 · Received April 22, 2010

    Report

    Report Number
    1718850-2010-00071
    Event Type
    Other
    Date Received
    April 22, 2010
    Date of Event
    August 4, 2009
    Report Date
    August 7, 2009
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE 510(K) NUMBER IS K071318. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED BY SORIN GROUP USA ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. DURING THE PROCEDURE, THE S5 ARTERIAL PUMP STOPPED AND DISPLAYED ERROR CODE "FAULT IN THE MOTOR CONTROLLER". THE PERFUSIONIST POWER CYCLED THE PUMP WITH NO SUCCESS. THE PUMP WAS CHANGED OUT. THE SORIN FIELD SERVICE ENGINEER COULD NOT REPRODUCE THE PROBLEM. THE PUMP WAS SENT TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. THE PUMP WAS SUBJECT TO AN ENDURANCE TEST OF APPROXIMATELY 800 HOURS. THE PROBLEM COULD NOT BE REPRODUCED. THE ELECTRONIC COMPONENTS DID NOT REVEAL ANY ABNORMALITIES. THE PUMP, HOWEVER, DID NOT START WHEN IT WAS FIRST POWER CYCLED. THE OSCILLATOR ON THE CIRCUIT BOARD MOTOR CONTROL MALFUNCTIONED. A DESIGN CHANGE WAS MADE TO THE CIRCUIT BOARD TO ELIMINATE THIS ISSUE. EXAMINATION CONFIRMED THAT THE CIRCUIT BOARD MOTOR CONTROL WAS BUILT BEFORE THE CHANGE WAS IMPLEMENTED. THIS IS AN INDEPENDENT ISSUE AND WOULD NOT CONTRIBUTE TO THE REPORTED PUMP STOPPAGE. THE CIRCUIT BOARD WAS REPLACED. THE PUMP WAS AGAIN SUBJECTED TO AN ENDURANCE TEST OF APPROXIMATELY 100 HOURS. NO PROBLEMS WERE FOUND. EXTENSIVE TESTING COULD NOT DUPLICATE THE PUMP STOPPAGE. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE S5 ARTERIAL PUMP STOPPED AND DISPLAYED ERROR CODE "FAULT IN THE MOTOR CONTROLLER". THE PERFUSIONIST POWER CYCLED THE PUMP WITH NO SUCCESS. THE PUMP WAS CHANGED OUT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1