BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG 34F DRAINAGE CANNULA

    MDR report key: 5021718 · Received August 21, 2015

    Report

    Report Number
    2916596-2015-01535
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 23, 2015
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END OF THE DRAINAGE CANNULA WAS CUT OFF AT THE HOSPITAL AND WAS RETURNED FOR INVESTIGATION. ADDITIONALLY, A PHOTO OF THE CANNULA AND BLUE SHRINK SEAL WAS RECEIVED. THE EVALUATION CONFIRMED THAT THE BLUE SHRINK SEAL WAS LOOSENED AND WAS NOT FITTED TO THE CANNULA PVC MATERIAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE REPORTED EVENT OF THE DISLODGED BLUE SHRINK SEAL IS BEING ADDRESSED THROUGH THE CORRECTIVE AND PREVENTIVE ACTION PROCESS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. THE DEVICE IS EXPECTED TO BE RETURNED. IT HAS NOT YET BEEN RECEIVED. THE EVENT OCCURRED AT (B)(6). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REQUIRED LEFT VENTRICULAR EXTRACORPOREAL CIRCULATORY SUPPORT. DURING INSERTION OF THE DRAINAGE CANNULA, WHILE IT WAS BEING PULLED THROUGH THE CHEST WALL, IT WAS NOTICED THAT THE BLUE SHRINK SEAL AT THE DISTAL END OF THE CANNULA WAS MISSING. AFTER A BRIEF SEARCH OF THE CHEST CAVITY, THE BLUE SHRINK SEAL WAS FOUND AND PLACED BACK ONTO THE CANNULA CLOSE TO THE ORIGINAL POSITION. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS AND THE OPERATION WAS CONCLUDED WITHOUT FURTHER INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556013 CENTRIMAG 34F DRAINAGE CANNULA CANNULA DWF THORATEC SWITZERLAND GMBH 2014071050

    Patients

    Seq Age Sex Outcome Treatment
    1