BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 6972720 · Received October 24, 2017

    Report

    Report Number
    1820334-2017-03642
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Report Date
    February 6, 2018
    Manufacturer
    COOK INC
    Product Code
    CBI
    UDI-DI
    00827002269071
    PMA / PMN Number
    K002288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K0219120. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS COMPLETED DURING THIS INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED AS IT WAS DISCARDED AT THE FACILITY; THEREFORE, NO PHYSICAL EXAMINATION COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS. IN ADDITION, THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE IFU SHIPPED WITH THE ARNDT ENDOBRONCHIAL BLOCKER SET STATES THAT THIS DEVICE IS INTENDED TO BE USED DURING PROCEDURES THAT REQUIRE ONE-LUNG VENTILATION AND THAT STANDARD TECHNIQUES FOR ENDOBRONCHIAL BLOCKERS SHOULD BE EMPLOYED. THE DEVICE IS NOT EXPECTED TO BE LEFT UNMONITORED OUTSIDE OF PROCEDURE. CUSTOMER TESTIMONY THAT IT WAS LEFT OVERNIGHT WITHOUT MONITORING IS AGAINST THE DEVICE'S INTENDED USE. A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED FAILURE MAYBE AN UNEXPECTEDLY LONG TIME IN USE WITHOUT MONITORING; HOWEVER, BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BALLOON PORTION OF AN ARNDT ENDOBRONCHIAL BLOCKER SET WOULD NOT REMAIN INFLATED WHEN USED IN THE PATIENT. THE PATIENT PRESENTED WITH BLEEDING IN THE LOWER RIGHT LUNG, SO THE OPERATOR ELECTED TO PLACE THE BLOCKER IN THE RIGHT MAIN STEM. THE BALLOON WAS THEN INFLATED TO BETWEEN 5 AND 6 CC'S OF AIR. THE ADAPTOR WAS THEN SCREWED DOWN, AND RENDERED IMMOVABLE. HOWEVER, UPON THE RESCOPING OF THE PATIENT THE FOLLOWING DAY, THE BALLOON WAS OBSERVED TO BE COMPLETELY DEFLATED. THE BALLOON WAS THEN RE-INFLATED AND SCREWED INTO PLACE ONCE MORE - THIS TIME WITH 7 CC'S OF AIR; BUT, 8 HOURS LATER, THE BALLOON WAS AGAIN FOUND TO BE DEFLATED. THE BLEEDING FINALLY CEASED FOLLOWING NUMEROUS BRONCHOSCOPIES USING COLD SALINE FLUSHES. THE PATIENT HAD EMPHYSEMA, AND WAS ON BLOOD THINNERS. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751222 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC N/A 00827002269071

    Patients

    Seq Age Sex Outcome Treatment
    1