BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 1668375 · Received April 23, 2010

    Report

    Report Number
    1718850-2010-00029
    Event Type
    Other
    Date Received
    April 23, 2010
    Date of Event
    October 13, 2005
    Report Date
    October 21, 2005
    Manufacturer
    SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4 )MANUFACTURES THE S3 ROLLER PUMP. THE 510(K) NUMBER IS K950990. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED 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. THE SORIN SERVICE TECH COULD NOT REPRODUCE THE PROBLEM. VISUAL INSPECTION FOUND NO ABNORMALITIES. AS A SAFETY MEASURE, TWO CIRCUIT BOARDS WERE CHANGED OUT. THE PUMP WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. THE PUMP WAS SUBJECTED TO A 76 HOUR TEST AND AN ENDURANCE TEST. THE REPORTED PROBLEM COULD NOT BE REPRODUCED. INSPECTION OF THE CIRCUIT BOARD CONNECTING PINS DID SHOW SOME OXIDATION WHICH CAN LEAD TO SPORADIC PUMP FAILURE. HOWEVER, THE ROOT CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. FUNCTIONAL TESTING SHOWED NO DEFECTS. SORIN GROUP (B)(4) CONCLUDED THAT THE PROBLEM COULD HAVE BEEN RESOLVED BY THE TECH WHEN HE CHANGED OUT THE CIRCUIT BOARDS. SORIN GROUP (B)(4) COULD NOT RE-CREATE THE PROBLEM. THERE WAS NO REPORT OF PT INJURY. THE FACILITY FILED A VIGILANCE REPORT WITH THE (B)(4) AUTHORITY. THIS MEDWATCH REPORT IS FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    AT THE START OF ECC, THE PUMP STOPPED AND THEN RESTARTED WITHOUT ANY INTERVENTION FROM THE CLINICIAN. NO ALARM OR ERROR CODE OCCURRED. ONE HOUR INTO THE PROCEDURE, THE PUMP AGAIN STOPPED. NO ALARM OR ERROR CODE OCCURRED. THE PUMP WAS POWER CYCLED AND THE LEVEL AND BUBBLE SENSORS WERE INACTIVATED BUT THE PUMP DID NOT RESTART. THE PUMP WAS CHANGED OUT TO CONTINUE THE CASE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1