BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS

    MDR report key: 21238154 · Received January 26, 2025

    Report

    Report Number
    3011175548-2025-000000
    Event Type
    Malfunction
    Date Received
    January 26, 2025
    Date of Event
    December 27, 2024
    Report Date
    March 7, 2025
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    UDI-DI
    00650862110012
    PMA / PMN Number
    K043140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION: B3.

    Additional Manufacturer Narrative · 0

    RELATED MDR: 3011175548-2025-0000008. RECEIVED A REPORT OF TWO ATRIUM DRAINS THAT HAD A CONTINUOUS AIR LEAK WHEN CONNECTED TO SUCTION. WHEN ASKED FOR ADDITIONAL INFORMATION, THE USER STATED THAT A DRAIN WAS PLACED ON A PATIENT FOLLOWING A "SUPRACORONARY ASCENDING AORTA REPLACEMENT." THE DRAIN WAS CONNECTED TO WALL SUCTION OF "-100" AND THE DRAIN'S SUCTION REGULATOR WAS SET TO "-20". THE DRAIN WAS CONNECTED TO A "NOVISCI 3 WAY Y CONNECTOR" (MOST LIKELY A NOVOSCI Y CONNECTOR, ALTHOUGH THE SIZE IS UNKNOWN) AND AN "ATRIUM CHEST TUBE." BOTH THIS DRAIN AND THE REPLACEMENT WERE ATTACHED TO THE PATIENT FOR LESS THAN 30 MINUTES. THE USER STATED THAT THE PACKAGING FOR THE DRAINS HAD ALREADY BEEN DISCARDED SO IT CANNOT BE EVALUATED FOR DAMAGE AND THE LOT NUMBERS ARE NOT KNOWN. BOTH DRAINS WERE RETURNED FOR EVALUATION. ONE WAS FULL OF COLLECTED PLUERAL FLUID, SOME OF WHICH HAD SPILLED INTO THE WATER SEAL CHAMBER. THE OTHER HAD A MUCH SMALLER AMOUNT OF FLUID IN IT. BOTH DRAINS WERE CLEANED AS WELL AS POSSIBLE AND VISUALLY INSPECTED. ON BOTH DRAINS, IN THE UPPER RIGHT CORNER (FACING THE FRONT OF THE DRAIN), UNDER THE PATIENT LINE NOZZLE, CRACKS AND WHITE STRESS MARKS CAN BE SEEN ON THE DRAIN BODY. SOME OF THE COLLECTED FLUID APPEARS TO HAVE WORKED ITS WAY INTO THE CRACKS. ONE OF THE DRAINS HAD TOO MUCH FLUID IN THE WATER SEAL CHAMBER AND COULD NOT BE ATTACHED TO WALL SUCTION WITHOUT GETTING CONTAMINATED FLUID IN THE SUCTION SYSTEM. THE OTHER WAS HOOKED UP TO SUCTION WITH THE SOURCE SET TO -80MMHG AND THE DRAIN REGULATOR SET TO -20CMH2O. A STEADY STREAM OF BUBBLES WERE SEEN MOVING RIGHT-TO-LEFT IN THE AIR LEAK DETECTION CHAMBER. THE PATIENT LINE WAS CLAMPED SHUT AND SLOWER, BUT STILL STEADY STREAM OF BUBBLES WAS STILL SEEN IN THE AIR LEAK DETECTION CHAMBER. THIS INDICATES AN AIR LEAK, CONFIRMING THE USER'S CONCERN. THE MOST LIKELY CAUSE OF THIS COMPLAINT IS SHIPPING DAMAGE. BOTH DRAINS HAD IDENTICAL DAMAGE TO THE DRAIN BODY WHICH IS TYPICALLY SEEN WHEN A CARTON IS IMPACTED DURING SHIPPING. A DHR REVIEW COULD NOT BE COMPLETED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. COMPLAINT TRENDING FOUND THAT THE ACTUAL OCCURRENCE LEVEL DID NOT EXCEED THE ANTICIPATED OCCURRENCE LEVEL. NO EXCURSIONS WERE IDENTIFIED. A COMPLAINT HISTORY REVIEW WAS COMPLETED WHICH FOUND 10 SIMILAR COMPLAINTS. THERE WERE NO RELATED CRS, CAPAS OR NCRS IDENTIFIED. THE CAUSE OF THE AIR LEAK WAS FOUND TO BE DAMAGE TO THE DRAIN COVER JUST BELOW THE PATIENT TUBE NOZZLE WHICH COMPROMISED THE INTERNAL PRESSURE OF THE DRAIN. THE INFORMATION REVIEWED IN THIS INVESTIGATION INDICATES THAT THIS DAMAGE WAS MOST LIKELY SUSTAINED DURING SHIPPING AND HANDLING OF THE DEVICE. THE ROOT CAUSE IS SUPPLY CHAIN - HANDLING DAMAGE. THIS INVESTIGATION CONFIRMED THE COMPLAINT AND THE DEVICE NONCONFORMANCE WILL BE ESCALATED TO (B)(4).

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    REPORT RECEIVED STATED THAT THE DRAIN HAD A CONTINUOUS AIR LEAK WHEN CONNECTED TO SUCTION. PATIENT WAS BEING TREATED FOR SUPRA CORONARY ASCENDING AORTA REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY JUST A DELAY FOR CHANGING OUT THE DRAIN ON AN UNSTABLE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831244 OASIS BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORPORATION 3600-100 00650862110012

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male NOVISCI 3-WAY Y CONNECTOR, ATRIUM CHEST TUBE.