BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS CHEST DRAIN

    MDR report key: 9993117 · Received April 23, 2020

    Report

    Report Number
    3011175548-2020-00573
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Report Date
    April 23, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS: BASED ON THE DETAILS OF THE COMPLAINT PROVIDED THE PHYSICIAN WAS NOT PLEASED THAT THE DRAIN SHOWED AIR LEAKS WHEN THE DRAIN VACUUM LINE WAS SHUT OFF. CORRESPONDENCE WITH THE INSTITUTION SHOWS THAT MULTIPLE QUESTIONS WERE MADE IN AN ATTEMPT TO BETTER UNDERSTAND THE SITUATION THAT THE PHYSICIAN WAS EXPERIENCING, HOWEVER, THE RESPONSE WAS THE FOLLOWING: ¿THIS SEEMS TO BE AN ISOLATED ISSUE AND THE TEAM DOES NOT FEEL A CONVERSATION IS NECESSARY AT THIS POINT IN TIME.¿ A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION IN REGARDS TO DISCONNECTING THE OASIS CHEST DRAIN: ¿SYSTEM DISCONNECTION CLAMP OFF PATIENT TUBES OR ALL INDWELLING THORACIC CATHETERS PRIOR TO DISCONNECTING CHEST DRAIN FROM PATIENT¿ THE REASON FOR CLAMPING THE PATIENT LINE IS TO PREVENT OPENING THE CHEST CAVITY TO THE ATMOSPHERE AND POTENTIALLY CREATING A PNEUMOTHORAX. CONCLUSION: BASED ON THE DETAILS PROVIDED ATRIUM MEDICAL CORPORATION CANNOT CONCLUDE THAT THE DRAIN WAS FAULTY. IT IS LIKELY THAT THE DRAIN WAS NOT CLAMPED AT THE PATIENT LINE AS SUGGESTED WITHIN THE IFU PRIOR TO TURNING OFF THE VACUUM SOURCE. H3 OTHER TEXT : NOT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED ISSUES DURING SURGERY WITH THE CHEST TUBES. HE STATED THE CHAMBER NEEDS TO BE CHANGED OUT AT LEAST TWICE AND THEN A THIRD TIME ON THE NURSING FLOOR. WHEN THE PATIENT GETS TAKEN OFF OF SUCTION IT SHOWS AN AIR LEAK WHICH MEANS THE PATIENT NEEDS TO STAY ANOTHER DAY. IF THE CHEST TUBE CHAMBER GETS CHANGED IT SHOWS NO AIR LEAK. SO THE ISSUE IS WHEN THE CHEST TUBES ARE BEING TAKEN OFF OF SUCTION THEY SHOW AIR LEAKS WHEN THE PATIENT REALLY DOES NOT HAVE ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456236 OASIS CHEST DRAIN APPARATUS, AUTOTRANSFUSION CAC ATRIUM MEDICAL CORPORATION 3600-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention