BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 SINGLE ROLLER PUMP

    MDR report key: 1668842 · Received April 21, 2010

    Report

    Report Number
    1718850-2010-00044
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    May 21, 2007
    Report Date
    May 30, 2007
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 ON BEHALF OF SORIN GROUP (B)(6). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO RECENT CHANGE IN SORIN GROUP (B)(6)'S MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. IT WAS REPORTED THAT THE PUMP STOPPED DURING THE PROCEDURE. THE PUMP WAS POWER CYCLED. THE CASE CONTINUED WITHOUT PROBLEMS. A SORIN SERVICE TECHNICIAN WAS DISPATCHED TO THE SITE TO INVESTIGATE THE PROBLEM. THE PROBLEM WAS CAUSED BY FAULTY INTERNAL CAN BUS CABLE. PIN ONE OF THE CABLE WAS NOT ENGAGED IN THE CONNECTOR HOUSING. THIS WAS CAUSED BY AN ASSEMBLY ERROR. THE CABLE WAS REPLACED AND NO FURTHER ISSUES WERE FOUND. THE CABLE WAS SENT TO THE SUPPLIER FOR EVAL. THE SUPPLIER RESPONDED THAT MANUFACTURING WAS MADE AWARE OF THE PROBLEM AND THE INDIVIDUALS RESPONSIBLE WERE SENSITIZED AND RE-TRAINED ACCORDINGLY. IN ADDITION, SORIN GROUP (B)(6) HAS INCREASED THEIR INCOMING INSPECTIONS. NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP STOPPED DURING THE PROCEDURE. THE PUMP WAS POWER CYCLED. THE CASE CONTINUED WITHOUT PROBLEMS. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1