BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA FOR SMALL CHILDREN, 6MM

    MDR report key: 10229624 · Received July 3, 2020

    Report

    Report Number
    3004582654-2020-00028
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 3, 2020
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040393
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION BY BERLIN HEART, ONLY NON-DESTRUCTIVE MICROSCOPIC IMAGING AND CT SCANS WERE PERFORMED. ALL ANALYSES WERE COMPLETED BY TWO INDEPENDENT INVESTIGATORS. THE CT SCANS WERE PERFORMED AT AN EXTERNAL INDEPENDENT LABORATORY UNDER THE OBSERVATION OF THE MANUFACTURER. DURING INITIAL VISUAL INSPECTION, IT WAS FOUND THAT THERE WERE TWO IMPACTED AREAS IN THE INFLOW CANNULA TRANSVERSE TO THE FLOW DIRECTION, CLOSE TO THE CONNECTOR. NO MARKS WERE FOUND ON THE INNER SIDE OF THE CANNULA AND ON THE POLISHED TITANIUM CONNECTOR. BASED ON THE ANALYSIS, THE CANNULA MUST HAVE BEEN IMPACTED IN TWO DIFFERENT AREAS FROM THE OUTSIDE. DUE TO THE SMALL AMOUNT OF BLOOD THAT LEAKED OUT OF THE CANNULA, IT WAS MOST LIKELY THE IMPACT FURTHER DOWN ON THE CONNECTOR THAT LEAD TO THE LEAKAGE. THE PERFORATION IN THE AREA OF THE FIRST IMPACT INDICATES THAT THE CANNULA WAS SQUEEZED WITH A FORCEPS-LIKE OBJECT. THE RESULTING CRACK PROGRESSES AND THIS EVENTUALLY LED TO THE LEAKAGE. THE SECOND IMPACT COULD THEORETICALLY ALSO HAVE OCCURRED WHEN THE CANNULA WAS CUT OFF OR SHORTENED. THE INSTRUCTIONS FOR USE FOR THE EXCOR VAD SYSTEM, REVISION 12 INCLUDES SEVERAL WARNINGS CAUTIONING THE USER AGAINST TOUCHING THE BLOOD PUMPS, CANNULAE AND DRIVING TUBES WITH POINTED OR SHARP OBJECTS.

    Additional Manufacturer Narrative · 1

    WE HAVE REVIEWED THE PRODUCTION RECORDS FOR THE EXCOR ARTERIAL CANNULA WITH LOT. NO 00078711. THIS CANNULA WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE AFFECTED CANNULA, LOT. NO. 00078711 WAS IN USE FROM (B)(6) 2019 UNTIL (B)(6) 2020 (414 DAYS). THE AFFECTED CANNULA IN USE BY THE PATIENT AT THE TIME OF THE INCIDENT HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. AN UPDATED REPORT WILL BE PROVIDED FOLLOWING A DETAILED INVESTIGATION.

    Description of Event or Problem · 1

    WE WERE INFORMED BY OUR (B)(6) DISTRIBUTOR ABOUT AN INCIDENT INVOLVING THE ARTERIAL CANNULA OF AN EXCOR PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE DISTRIBUTOR REPORTED THAT THE ARTERIAL CANNULA HAD A CRACK. THE AFFECTED EXCOR OUTLET CANNULA WAS SHORTENED BY TRAINED SPECIALIST PERSONNEL IN THE CLINIC AND THE EXCOR BLOOD PUMP WAS REPLACED. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT AND WE WERE INFORMED THAT THE PATIENT WAS WELL AFTER THE SHORTENING OF THE CANNULA AND EXCHANGING THE BLOOD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692992 ARTERIAL CANNULA FOR SMALL CHILDREN, 6MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH C80G-021 04260090040393

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO