BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCEAN SINGLE DRAIN

    MDR report key: 7292552 · Received February 23, 2018

    Report

    Report Number
    3011175548-2018-00178
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 23, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    KDQ
    PMA / PMN Number
    K043582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRAIN WAS NOT RETURNED FOR EVALUATION. BASED ON THE DETAILS PROVIDED FROM THE PHYSICIAN THE OCEAN DRAIN WAS FILLED CORRECTLY AND THEN ATTACHED TO INCREDIBLY HIGH WALL SUCTION WHICH CAUSED THE SUCTION CONTROL WATER TO SURGE AND CASCADE INTO THE WATER SEAL. THE HIGH WALL SUCTION WAS SUSTAINED AND RESULTED IN RAPID BUBBLING IN THE SUCTION CONTROL CHAMBER CAUSING THE WATER TO EVAPORATE RAPIDLY. PER THE OCEAN INSTRUCTION FOR USE (IFU) THE SUCTION SHOULD BE INCREASED UNTIL A CONSTANT GENTLE BUBBLING IN THE SUCTION CONTROL CHAMBER IS ACHIEVED. THIS NEEDS TO BE CONTROLLED AT THE SUCTION SOURCE (WALL REGULATOR) AS THE 2002-400 OCEAN DRAIN DOES NOT HAVE A SUCTION CONTROL STOPCOCK TO CONTROL THE AMOUNT OF BUBBLING. THE DEVICE HISTORY RECORDS ASSOCIATED WITH THIS LOT WERE REVIEWED AND FOUND TO HAVE MET SPECIFICATIONS. CLINICAL EVALUATION: THE OCEAN CHEST DRAIN SYSTEM IS INDICATED FOR THE EVACUATION OF AIR AND/OR FLUID FROM THE CHEST CAVITY OR MEDIASTINUM AND TO HELP RE-ESTABLISH LUNG EXPANSION AND RESTORE BREATHING DYNAMICS. IT ALSO WILL FACILITATE POSTOPERATIVE COLLECTION AND REINFUSION OF AUTOLOGOUS BLOOD FROM THE PATIENT¿S PLEURAL CAVITY OR MEDIASTINAL AREA. THE IFU PROVIDES STEP BY STEP INSTRUCTIONS IN THE SET-UP OF THE DRAIN. IT IS AN EXPECTATION IN THE USE OF THIS DEVICE THAT CLOSE MONITORING OF THE DRAIN SHOULD BE CONDUCTED AT REGULAR INTERVALS BY A KNOWLEDGEABLE CLINICIAN TO ENSURE PROPER FUNCTIONING.

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    REPORT RECEIVED STATED THAT THE DRAIN WAS HOOKED UP TO THE PATIENT AND THE SUCTION CONTROL CHAMBER WAS FILLED. APPROXIMATELY 12 HOURS LATER THE SUCTION CONTROL CHAMBER WAS FOUND TO BE EMPTY AND THE FLUID WAS MIXED BETWEEN THE COLLECTION CHAMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135647 OCEAN SINGLE DRAIN BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL 2002-400 249536

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention