BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR PARIS %

    MDR report key: 2022178 · Received March 11, 2011

    Report

    Report Number
    1718850-2011-00015
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    April 18, 2008
    Report Date
    April 21, 2008
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K022450
    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) MANUFACTURERS THE SYNTHESIS OXYGENATOR. THE OXYGENATOR IS A COMPONENT OF THEIR CUSTOM PERFUSION PACK. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE AS A RESULT OF A CHANGE IN SORIN GROUP (B)(4)'S COMPLAINT REPORTING CRITERIA AND SUBSEQUENT REVIEW OF THE PAST COMPLAINTS TO THESE CRITERIA. SORIN GROUP (B)(4) RECEIVED A REPORT OF BLOOD LEAKING FROM THE SYNTHESIS OXYGENATOR DURING A HEART VALVE REPLACEMENT PROCEDURE. THE REPORT INDICATES THAT THE LEAK SEEMED TO ORIGINATE FROM A CONNECTOR BETWEEN THE MEMBRANE AND THE INTEGRATED ARTERIAL FILTER. ALTHOUGH BLOOD LOSS WAS REPORTED, THE AMOUNT IS UNK. IT WAS ALSO REPORTED THAT THERE WERE NO PT CONSEQUENCES. SORIN GROUP (B)(4) HAS COMPLETED THEIR EVALUATION OF THE RETURNED PRODUCT. VISUAL INSPECTION REVEALED THAT THE ARTERIAL FILTER WAS DISCONNECTED FROM THE OXYGENATOR. THE MECHANICAL HOOKS WHICH CONNECT THE TWO PIECES WERE BROKEN AND THE BREAKAGE CREATED A LEAK PATH. A CAREFUL INSPECTION OF THE MANUFACTURING PROCESS AND DEDICATED TESTS FOR RESIN ADHESION SHOWED THAT THE PRODUCT MET SPECIFICATION. A REVIEW OF THE DHR CONFIRMED THAT THIS UNIT PASSED A 100% VISUAL INSPECTION BEFORE EXITING THE PRODUCTION AREA. THE OXYGENATOR IS PACKAGED IN A VALIDATED PROTECTIVE PACKAGING AND IS ABLE TO RESIST A FALL WITHOUT BREAKING. HOWEVER, THE OXYGENATOR CAN EXPERIENCE DAMAGE IF IT IS SUBJECTED TO A SHARP BLOW OR FALL OUTSIDE THE PACKAGE. SORIN GROUP (B)(4) CONCLUDED THAT THE BREAKAGE WAS CAUSED BY AN ACCIDENTAL IMPACT AFTER ASSEMBLY OF THE OXYGENATOR AND BEFORE FINAL ASSEMBLY AND PACKAGING OF THE CUSTOM PERFUSION PACK. IN ORDER TO PREVENT THIS FROM RE-OCCURRING. SORIN GROUP (B)(4) HAS IMPLEMENTED AN IMPROVED INTERNAL HANDLING AND TRANSPORTATION SYSTEM DURING THE SECOND PHASE OF PRODUCTION AND INSTRUCTED MANUFACTURING PERSONNEL TO INSPECT THE INTEGRITY OF THE MECHANICAL HOOKS. ALSO, CONTENT WAS ADDED TO THE INSTRUCTIONS FOR USE WHICH INSTRUCT THE USER TO VERIFY THE INTEGRITY/STABILITY OF THE CONNECTION BETWEEN THE OXYGENATOR AND THE ARTERIAL FILTER DURING PREPARATION AND SETUP. THERE WAS NO REPORT OF PT INJURY. THE FACILITY REPORTED BLOOD LOSS. ALTHOUGH THE AMOUNT WAS UNK, THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    DURING A HEART VALVE REPLACEMENT PROCEDURE, A LEAK OCCURRED FROM THE SYNTHESIS OXYGENATOR. IT APPEARED THAT THE LEAK WAS AT THE CONNECTOR BETWEEN THE OUTLET PORT OF THE MEMBRANE AND THE INLET PORT OF THE ARTERIAL FILTER. THE FACILITY REPORTED THAT THERE WAS BLOOD LOSS. THE AMOUNT OF BLOOD LOSS WAS NOT PROVIDED. IT WAS ALSO REPORTED THAT THERE WERE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR PARIS % CUSTOM HEART LUNG PERFUSION PACK DTZ SORIN GROUP ITALIA NA 0712100090

    Patients

    Seq Age Sex Outcome Treatment
    1