BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAINS OASIS SINGLE

    MDR report key: 15447814 · Received September 19, 2022

    Report

    Report Number
    3011175548-2022-00260
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Report Date
    April 13, 2023
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    UDI-DI
    00650862110012
    PMA / PMN Number
    K043140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT CLAIMS THAT THE USER ATTEMPTED TO "FLUSH" THE DRAIN THROUGH THE PORT "LEFT OF THE BLUE SUCTION VALVE." . TWO POSSIBLE MEANINGS ARE BEING CONSIDERED FOR THIS, DEPENDING ON HOW THE USER MAY HAVE THE DRAIN ORIENTED WHEN DESCRIBING THE LOCATION OF THE "PORT." THE USER DID NOT RETURN THE DRAIN OR PROVIDE PICTURES. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION FROM THE COMPLAINANT, BUT NO RESPONSE WAS RECEIVED. THEY MAY MEAN THEY ARE ATTEMPTING TO EMPTY THE DRAIN THROUGH THE PPRV, WHICH IS NOT THE INTENDED PURPOSE OF THE PPRV. THE PPRV (POSITIVE PRESSURE RELEASE VALVE) IS INTENDED TO ALLOW FLUID TO EXIT THE DRAIN WHEN THE DRAIN FILLS OR HAS POSITIVE PRESSURE. THIS ALLOWS THE DRAIN TO CONTINUE TO FUNCTION UNTIL IT CAN BE REPLACED. THE IFU INSTRUCTS THE USER TO REPLACE THE DRAIN IF IT BECOMES FULL, SO THE USER SHOULD NOT BE ATTEMPTING TO EMPTY IT. IF THEY POUR FLUID THROUGH THE PPRV, IT IS POSSIBLE FOR IT TO CONGEAL IN THE VENT, CLOGGING IT AND PREVENTING ANY MORE FLUID FROM BEING ABLE TO PASS THROUGH. THEY MAY ALSO MEAN THAT THEY DEPRESSED THE MVV TO ATTEMPT TO RELIEVE THE NEGATIVE PRESSURE IN THE DRAIN AND LOWER THE HEIGHT OF THE WATER SEAL COLUMN AND THE SPRING MECHANISM BECAME STUCK. BECAUSE IT IS NOT CLEAR WHICH SCENARIO THE USER IS DESCRIBING AND THEY DID NOT PROVIDE ANY FURTHER INFORMATION WHEN ASKED, A DEFINITE ROOT-CAUSE CANNOT BE DETERMINED. THE ROOT-CAUSE OF THIS COMPLAINT IS IMPOSSIBLE TO DEFINE. A DHR REVIEW COULD NOT BE COMPLETED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. RELEVANT MANUFACTURING PROCEDURES AND DEVICE/PART SPECIFICATIONS WERE REVIEWED AND NO CHANGES OR INADEQUACIES WERE IDENTIFIED WHICH WOULD LIKELY CONTRIBUTE TO THIS COMPLAINT. THE IFU PROVIDES ADEQUATE INSTRUCTIONS FOR THE SETUP AND USE OF THE DEVICE AND CONTAINS ALL THE INFORMATION REQUIRED TO AVOID THIS FAILURE. BECAUSE THE DEVICE WAS NOT RETURNED AND NO IMAGES OR ANY OTHER EVIDENCE OF THE INCIDENT WAS PROVIDED, THIS COMPLAINT CANNOT BE CONFIRMED. A DEVICE NONCONFORMITY CANNOT BE CONFIRMED WITH THE PROVIDED INFORMATION OR WITH THE INFORMATION REVIEWED IN THIS INVESTIGATION. A DEFINITE ROOT-CAUSE CANNOT BE DETERMINED BECAUSE IT IS NOT CLEAR EXACTLY WHAT FAILURE OCCURRED. THE ROOT-CAUSE FOR THIS COMPLAINT IS IMPOSSIBLE TO DEFINE. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    PER CUSTOMER'S EMAIL: THEY EXPERIENCED PORTS ON TWO OF THE #3600-100 FAIL ON THEM, TO THE LEFT OF THE BLUE SUCTION VALVE. THEY WENT TO FLUSH AND THE PORT BECAME STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2475708 DRAINS OASIS SINGLE BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORPORATION 3600-100 00650862110012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown