BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE METER

    MDR report key: 8465650 · Received March 29, 2019

    Report

    Report Number
    3007966929-2019-00007
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Manufacturer
    UNOMEDICAL ZAVODSKAYA STREET 50
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STOP FLOW ISSUE OCCURRED WHEN USING UNOMETER 500 DEVICES, SPECIFICALLY ON INTENSIVE CARE UNIT (ICU) PATIENTS WITH LOW URINE OUTPUT. IT WAS FURTHER REPORTED THAT THIS HAS BEEN AN ONGOING ISSUE THAT STARTED APPROXIMATELY TWO MONTHS AGO WHEN THEY FIRST STARTED USING UNOMETER DEVICES. IT WAS REPORTED THAT URINE WAS BEING STOPPED IN THE ENTRANCE OF THE TUBING INTO THE CHAMBER (RIGHT WHERE THERE IS THE ANTI-KINKING SPIRAL) AND IN THE FOLEY CATHETER, RIGHT BEFORE GETTING INTO THE KOMBIKON CONNECTOR. IT WAS REPORTED THAT IT LOOKS LIKE THERE IS SOME VACUUM PRESSURE THAT DOES NOT LET THE NON-RELEASE VALVE (NVR) TO OPEN. THE NURSE REPORTED THAT TO ALLOW URINE TO FLOW, THEY CURRENTLY OPEN THE SYSTEM BY DISCONNECTING THE FOLEY (AND THEN ALL THE URINE FLOWS DOWN DIRECTLY. THE REPORTER INDICATED THAT IN SOME CASES ¿EVEN 40ML HAS FALLEN DOWN TO THE CHAMBER ALL OF A SUDDEN". IT WAS ALSO REPORTED THAT ANOTHER OPTION THEY DO SOMETIMES IS TO ¿MILK¿ THE TUBING, BUT WHEN USING THIS METHOD, ¿SOME OF THE URINE FALLS TO THE CHAMBER BUT NOT AS MUCH AS WITH OPENING THE SYSTEM". THE DEVICES ARE KEPT IN PLACE. DISCONNECTING THE FOLEY RESOLVES THE URINE PRESENT IN THE TUBING, BUT THE ISSUE RETURNS EACH TIME THE FOLEY IS RE-CONNECTED. THE REPORTED COULD NOT PROVIDE THE EXACT NUMBER OF PATIENTS FOR WHICH THIS ISSUES HAD OCCURRED, SO THIS RECORD WAS CREATED TO CAPTURE AND REPORT THIS INFORMATION. THERE HAS BEEN NO REPORTED PATIENT HARM. A VIDEO DEPICTING THE REPORTED ISSUE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256740 URINE METER DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL ZAVODSKAYA STREET 50 25001183

    Patients

    Seq Age Sex Outcome Treatment
    1