BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS

    MDR report key: 21300832 · Received February 3, 2025

    Report

    Report Number
    3011175548-2025-000001
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 17, 2025
    Report Date
    March 17, 2025
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    UDI-DI
    00650862110012
    PMA / PMN Number
    K043140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED MDR: 3011175548-2025-0000012, 3011175548-2025-0000013. THE USER REPORTED THAT AN OASIS DRAIN LEAKED WHILE IN USE ON A PATIENT. THEY THEN TESTED TWO MORE DRAINS FROM THE SAME LOT WITHOUT ATTACHING THEM TO THE PATIENT AND THEY BOTH LEAKED AS WELL. ALL THREE COMPLAINTS ARE FOR OASIS DRAINS (P/N 3600-100, L/N 509742). THE REPORT STATED THEY WERE LEAKING FROM THE LOWER LEFT EDGE (IT IS ASSUMED THIS IS MEANT FACING THE BACK OF THE DRAIN, AS THE PROVIDED PICTURES ALL SHOW DAMAGE AND LEAKING AT THE LOWER RIGHT CORNER, UNDER THE PATIENT LINE NOZZLE). PICTURES WERE PROVIDED WHICH ALL FOCUS ON THE BOTTOM CORNER UNDER THE PATIENT LINE NOZZLE. ALL THREE DRAINS APPEAR TO BE LEAKING CLEAR FLUID. THE CUSTOMER STATED THAT THE FIRST DRAIN BEGAN LEAKING WHILE IN USE ON A PATIENT. HOWEVER IT DOES NOT APPEAR TO BE PLEURAL FLUID LEAKING OUT. THE FLUID LEAKING OUT IS CLEAR. THE USER DESCRIBES CORRECTLY FILLING THE WATER SEAL THROUGH THE BLUE SUCTION NOZZLE, WHICH SHOULD FILL THE WATER SEAL AND TURN BLUE WHEN IT CONTACTS THE BLUE DYE BALL. THE PICTURE SHOWING THE PLEURAL FLUID DOES NOT SHOW THE WATER SEAL CHAMBER SO IT CANNOT BE CONFIRMED VISUALLY IF IT WAS FILLED CORRECTLY. THE ONLY PICTURE RECEIVED THAT SHOWS THE WATER SEAL CHAMBER IS FOR ONE OF THE DRAINS THAT WAS TESTED WITHOUT A PATIENT, AND THAT ONE DOES NOT APPEAR TO HAVE FLUID IN THE WATER SEAL CHAMBER. THAT PICTURE SHOWS LEAKED FLUID AT THE LOWER RIGHT CORNER AND THERE IS RESIDUAL WATER LEFT IN THE PATIENT LINE. THE USER ALSO PROVIDED PICTURES OF THE DRAINS' PACKAGING WHICH IS DENTED IN THE LOWER CORNER, CONSISTENT WITH THE LOCATION OF THE LEAKS. PICTURES OF THE DRAINS SHOW WHITE STRESS MARKS IN THAT SAME LOWER RIGHT CORNER. THE DAMAGE TO THE DRAINS AND PACKAGING IS CONSISTENT WITH AN IMPACT SUCH AS THE SHIPPING BOX BEING DROPPED ON A LOWER EDGE. A DHR REVIEW WAS COMPLETED AND NO ANOMALIES IN MANUFACTURING WERE IDENTIFIED. THE PACKAGING DAMAGE SEEN IN THE PICTURES INDICATES THIS MOST LIKELY OCCURRED AFTER MANUFACTURING WHEN THE DRAINS WERE PACKAGED TOGETHER. THE IFU PROVIDES ADEQUATE INSTRUCTIONS FOR THE SETUP AND USE OF THE DEVICE. THE IFU INSTRUCTS THE USER NOT TO USE THE DEVICE IF IT OR THE PACKAGING IS DAMAGED. THE HAZARDOUS SITUATION/HARM IS ADDRESSED IN THE HARM HAZARDS ANALYSIS DOCUMENT WHICH ASSIGNS IT A SEVERITY LEVEL OF 1. THIS WAS DETERMINED TO BE APPROPRIATE BASED ON THE HARM THAT WAS REPORTED IN THE COMPLAINT. COMPLAINT TRENDING CONCLUDED THAT THE ACTUAL OCCURRENCE LEVEL DID NOT EXCEED THE ANTICIPATED OCCURRENCE LEVEL. NO EXCURSIONS WERE IDENTIFIED. THIS INVESTIGATION CONFIRMED THE DEVICE NONCONFORMANCES AND REQUIRES ESCALATION, HOWEVER CORRECTIVE ACTION REQUEST (1242757) IS ALREADY OPENED FOR THIS ISSUE SO THESE COMPLAINTS WILL BE INCLUDED WITHIN THE INVESTIGATION. THE PROVIDED PICTURES SHOW DAMAGE TO THE PACKAGING AND TO THE LOWER RIGHT CORNER OF THE DRAINS (UNDER THE PATIENT NOZZLES). THE MOST LIKELY CAUSE OF THIS IS AN IMPACT TO THE SHIPPING BOX THAT THE DRAINS WERE PACKAGED IN WHICH DAMAGED THE DRAIN COVER WELD, COMPROMISING THE SEAL OF THE DRAIN. BOTH THE COMPLAINTS AND A DEVICE NONCONFORMANCES ARE CONFIRMED. THE ROOT CAUSE OF THESE COMPLAINTS IS SUPPLY CHAIN - HANDLING DAMAGE.

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED. DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL'S PULMONOLOGY TECHNIQUES DEPARTMENT REPORTED THAT THE CHEST DRAINAGE BOX LEAKS FLUID FROM THE LOWER LEFT EDGE. THREE UNITS FROM THE SAME BATCH WERE TESTED, ALL SHOWING THE SAME DEFECT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64866 OASIS BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORPORATION 3600-100 509742 00650862110012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female