BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR SET FOR CANNULAS Ø 6/9MM

    MDR report key: 6021782 · Received October 12, 2016

    Report

    Report Number
    3004582654-2016-00037
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040591
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE AFFECTED CONNECTOR SET WAS RETURNED STILL CONNECTED TO THE EXCOR BLOOD PUMP. AT THE REGION OF TRANSITION OF THE CONNECTING SET TUBING TO THE TITANIUM CONNECTORS ON BOTH SIDES (PUMP INLET AND OUTLET) WHITISH AND REDDISH-BROWN RESIDUES WERE OBSERVED. THE CONSISTENCY OF THE RESIDUE WAS TESTED AND FOUND TO BE SIMILAR TO A GREASY ORGANIC SUBSTANCE. THERE IS NO EVIDENCE OF POTENTIALLY ABRADED SILICON MATERIAL. IT IS HIGHLY PROBABLE THAT THE DETECTED RESIDUES ORIGINATED FROM AN ORGANIC SUBSTANCE THAT WAS TRANSPORTED BY BLOOD AND DEPOSITED AT THE TRANSITION REGION AMONGST OTHER PLACES. NO DAMAGE SUCH AS CUTS OR BREAKS COULD BE FOUND AT EITHER OF THE TRANSITIONS (PUMP INLET AND OUTLET) OF THE CONNECTING SET TUBING TO THE TITANIUM CONNECTOR. TUBING WAS VISUALLY INSPECTED UNDER MICROSCOPE AND NO DEFECTS WERE DETECTED. NO DEFECT OF THE CONNECTOR SET WAS DETECTED DURING THE FAILURE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE EXCOR CONNECTOR SET (LOT NO.00050407) WAS IN USE FROM (B)(6) 2016 (59 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR CONNECTOR SET FOR CANNULAS LOT 00050407. THIS CONNECTOR SET WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE AFFECTED CONNECTOR SET WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING PRELIMINARY VISUAL INSPECTION, NO OPTICAL ANOMALIES WERE DETECTED. DETAILED EVALUATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 0

    THE SITE INFORMED BERLIN HEART CLINICAL AFFAIRS(CA) THAT THERE WAS AN EXCHANGE OF THE CONNECTOR SET FOR CANNULAS AND EXCOR BLOOD PUMP FOR A PATIENT SUPPORTED IN LVAD CONFIGURATION. THE SITE REPORTED THAT A "WHITE SPOT" WAS OBSERVED ON THE CONNECTING SET 24 HOURS PRIOR TO THE EVENT DATE, WHICH BECAME PROGRESSIVELY LARGER. UPON FURTHER INSPECTION, THE CONNECTOR SET TUBING APPEARED TO HAVE A BREACH ON THE INSIDE. THE PUMP PERFORMANCE WAS MAINTAINED AS INTENDED THROUGHOUT THE EVENT. TRAINED PERSONNEL AT THE CLINIC REPLACED THE AFFECTED CONNECTOR SET AND EXCOR BLOOD PUMP. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE EXCHANGE OF THE CONNECTOR SET WELL WITH NO UNTOWARD EFFECT. THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671483 CONNECTOR SET FOR CANNULAS Ø 6/9MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH A06-009 00050407 04260090040591

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR