BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCEAN CHEST DRAIN

    MDR report key: 4810865 · Received June 1, 2015

    Report

    Report Number
    1219977-2015-00159
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 26, 2015
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    PMA / PMN Number
    K043582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING THE RETURN OF THE DEVICE FOR INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE IN-LINE CONNECTOR (ILC) ASSEMBLY ON THE PATIENT LINE TUBE SET REPORTEDLY WOULD NOT CLICK INTO LOCKED POSITION WHEN RECONNECTED. THIS MEANS THAT TWO HALVES OF THE IN-LINE CONNECTOR ASSEMBLY WOULD NOT LATCH/LOCK TOGETHER UPON RE-CONNECTION DURING USE. EXAMINATION OF THE RETURNED DEVICE ILC ASSEMBLY TO BE SLIGHTLY OFF CENTER AS COMPARED TO A DIFFERENT ILC ASSEMBLY. THE ILC ASSEMBLY IS CONSTRUCTED OF PLASTIC MOLDED COMPONENTS. WHEN THE SLIDE IS ACTIVATED IT PUSHES AGAINST THE SPRING TAB TO ALLOW SEPARATION OF THE TWO HALVES OF THE ILC. THE SPRING TAB WILL RETURN THE SLIDE TO THE LOCKED POSITION. WHEN THE TWO HALVES ARE RECONNECTED, THE SLIDE MOVES AND THE TWO HALVES LOCK IN PLACE. HOWEVER, IF THE TRIGGER ON THE SLIDE AND THE SPRING FEATURE ARE NOT ALIGNED, THE ILC WOULD NOT LOCK THE TWO HALVES TOGETHER. FURTHER ANALYSIS OF THE ILC ASSEMBLY WHEN DISSECTED, REVEALED THAT THE SPRING/TAB IS SLIGHTLY BENT OFF CENTER TOWARDS THE TOP END. ADDITIONALLY, THE TRIGGER FEATURE ON THE SLIDE IS SLIGHTLY DEFORMED ON THE SAME SIDE. THE DEFORMED SLIDE/SPRING MECHANISM THAT IS RESPONSIBLE FOR LOCKING THE TWO HALVES OF THE ILC ASSEMBLY WAS THE REASON WHY THE ILC DID NOT LOCK INTO PLACE AS REPORTED. DURING THE AUTOMATED MANUFACTURING PROCESS, EACH ILC ASSEMBLY IS FULLY VERIFIED FOR THE PRESENCE OF THE SLIDE AND THE FORCE TO INSERT THE SLIDE INTO THE ILC HOUSING. THE FORCE IS MEASURED AND NEEDS TO BE WITHIN A SET RANGE. IN SUMMARY THE AUTOMATED ASSEMBLY EQUIPMENT IS LOOKING FOR THE PRESENCE AND FUNCTIONALITY OF THE SPRING/TAB FEATURE ON THE ILC HOUSING. ADDITIONALLY, EACH ILC ASSEMBLY IS FULLY VERIFIED THROUGH AN AUTOMATED LEAK TEST. THE EVIDENCE GATHERED DURING THE ANALYSIS OF THE RETURNED ILC ASSEMBLY SHOWS THAT THE LOCKING MECHANISM THAT KEEPS THE TWO HALVES FROM COMING APART WAS NOT FUNCTIONING PROPERLY. AS A RESULT OF THE SPRING TAB BEING OFF CENTER AND THE DEFORMATION ON THE TRIGGER FEATURE OF THE SLIDE, THE ILC ASSEMBLY REMAINED IN THE UNLOCKED POSITION, HOWEVER THE EXACT ROOT CAUSE IS UNK.

    Additional Manufacturer Narrative · 1

    MDR BEING SUBMITTED IN ORDER TO LINK THE USER FACILITY MEDWATCH WITH THE MANUFACTURER SUBMITTED MDR. (B)(4).

    Description of Event or Problem · 1

    RECEIVED A REPORT THAT DURING A CHANGE OUT OF A CHEST DRAIN THE IN-LINE CONNECTOR ON THE NEW DRAIN WOULD NOT CLICK INTO THE CHEST TUBE FULLY. WHEN THE CONNECTOR BUTTON WAS PUSHED IT EASILY RELEASED FROM THE DRAIN. THE PATIENT WAS CLAMPED THE ENTIRE TIME DURING THE CHANGE OUT SO NO HARM TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352657 OCEAN CHEST DRAIN BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORP. 2002-000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR