BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD CARDIOPLEGIA INSERTS

    MDR report key: 1645280 · Received March 24, 2010

    Report

    Report Number
    1718850-2010-00051
    Event Type
    Malfunction
    Date Received
    March 24, 2010
    Date of Event
    October 9, 2007
    Report Date
    October 11, 2007
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED USING VARIOLOCK BLOOD CARDIOPLEGIA INSERTS TO BE USED WITH AN S3 PUMP SYSTEM. THE 510(K) NUMBER FOR THE S3 ROLLER PUMP MODULE AND CONSOLE IS K950990. 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. THE PERFUSIONIST REPORTED THAT THE CARDIOPLEGIA TUBING JAMMED THE PUMP ROTOR. THE TUBING WAS HELD IN PLACE BY VARIOLOCK INSERTS. AN ATTEMPT WAS MADE TO REFIT THE TUBING BUT WAS UNSUCCESSFUL. THE PUMP WAS CHANGED OUT. THE REPLACEMENT PUMP WAS EQUIPPED WITH PLASTIC INSERTS. NO FURTHER PROBLEMS OCCURRED. SORIN GROUP (B)(4) RECEIVED CARDIOPLEGIA INSERTS, AS WELL AS TRACK GUIDES FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY ABNORMALITIES. INSPECTION OF THE TRACK GUIDES IN RELATION TO THE POSITION OF THE TUBING INSERTS WAS PERFORMED. TESTING INCLUDED MEASURING THE FORCE REQUIRED TO PHYSICALLY MOVE THE TUBING HELD BY THE INSERTS BY VARYING THE PUMP OCCLUSION AND, THEREFORE, EVALUATING THE FORCE APPLIED BY THE PUMP ROTOR. A RETAINING FORCE, THE ACTUAL FORCE REQUIRED TO DRAW THE TUBING OUT OF THE INSERTS, WAS ALSO MEASURED. RESULTS INDICATED THAT THE VARIOLOCKS REQUIRED MORE FORCE TO MOVE OR PULL TUBING OUT OF THE INSERTS AS COMPARED TO THE PLASTIC INSERTS. THE RESULT, THE VARIOLOCKS WOULD HOLD THE TUBING IN PLACE MORE SECURELY THAN THE PLASTIC INSERTS, MAKING IT MORE DIFFICULT TO MOVE AND BECOME JAMMED. ANALYSIS OF THE GUIDE TRACKS DID NOT REVEAL ANY ISSUES. BASED ON THE INVESTIGATION, SORIN GROUP (B)(4) HAS CONCLUDED THAT THE VARIOLOCK INSERTS AND GUIDE TRACKS DID NOT CONTRIBUTE TO THE INCIDENT. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT THE CARDIOPLEGIA TUBING JAMMED THE PUMP ROTOR. THE TUBING WAS HELD IN PLACE BY VARIOLOCK INSERTS. AN ATTEMPT WAS MADE TO REFIT THE TUBING BUT WAS UNSUCCESSFUL. THE PUMP WAS CHANGED OUT. THE REPLACEMENT PUMP WAS EQUIPPED WITH PLASTIC INSERTS. NO FURTHER PROBLEMS OCCURRED. THE PATIENT WAS CROSS-CLAMPED FOR ELEVEN MINUTES PRIOR TO RECEIVING CARDIOPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD CARDIOPLEGIA INSERTS VARIOLOCK INSERTS DTQ SORIN GROUP DEUTSCHLAND 10-61-93 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP