BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO

    MDR report key: 5993797 · Received October 3, 2016

    Report

    Report Number
    2025816-2016-00197
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    June 1, 2016
    Report Date
    September 30, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# REVIEW: REPORTED LOT# 3251288 (MFG. 05/2016); LOT# 3260656* (MFG. 05/2016) AND LOT# 3261516* (MFG. 05/2016) (B)(4) UNITS. THERE WERE NON EXCEPTION DOCUMENTS FOR THE TREE LOTS. (B)(4) ANALYSIS: 9/23/2016 - ON 9/21/2016 RECEIVED SIX (6) USED D1000 TEGO CONNECTORS REPORTED LOT# 3251288, 3260656 AND 3261516. NO MATING DEVICES WERE RETURNED. THE DEVICES WERE RETURNED WITH NUMBER IDENTIFICATION. TEGO #11; THE SILICONE WAS OBSERVED TO BE TORN NEAR THE TOP RIM. TEGO #1, BLOOD WAS OBSERVED UNDER THE SILICONE SEAL. TEGO #33, TWO TEGOS WERE RETURNED. THE SILICONE WAS OBSERVED TO BE TORN NEAR THE TOP RIM FOR BOTH TEGOS. TEGO #32, TWO TEGOS WERE RETURNED. THE SILICONE WAS OBSERVED TO BE TORN NEAR THE TOP RIM FOR BOTH TEGOS. FUNCTIONAL/PERFORMANCE TESTING: FOUR BAGS CONTAINING D1000 TEGO CONNECTORS WERE RETURNED FOR INVESTIGATION OF LEAKAGE. EACH OF THE BAGS WAS NUMBERED AND WILL BE REFERENCED WITH THE NUMBERS ON THE BAGS. TEGO #11, ONE D1000 TEGO WAS RETURNED IN THIS BAG. THE SEAL WAS TORN BELOW THE TOP RIM NEAR THE THREAD POST. TEGO #1, ONE D1000 TEGO WAS RETURNED IN THIS BAG. BLOOD WAS OBSERVED BETWEEN THE BODY AND THE SEAL. TEGO #33, TWO D1000 TEGO CONNECTORS WERE RETURNED IN THIS BAG. BOTH HAD TEARS BELOW THE TOP RIM NEAR THE THREAD POSTS. TEGO #32, TWO D1000 TEGO CONNECTORS WERE RETURNED IN THIS BAG. BOTH HAD TEARS BELOW THE TOP RIM NEAR THE THREAD POSTS. EACH OF THE RETURNED D1000 TEGO CONNECTORS WERE TESTED AT 40PSI FOR PRIMARY SEAL INTEGRITY BETWEEN THE BODY POST AND THE ONE PIECE SEAL. TEGO 11, PASS. TEGO 1, SLITS ON BOTH SIDES OF THE PRIMARY SEAL AREA, FAILED. TEGO 33, BOTH PASS. TEGO 32, BOTH PASS. EACH OF THE RETURNED D1000 TEGO CONNECTORS WERE TESTED FOR SLIT SEAL INTEGRITY. TEGO 11: PASS. TEGO 33: BOTH PASS. TEGO 32: BOTH PASS. FINAL ANALYSIS SUMMARY: THE COMPLAINT OF D1000 TEGO LEAKAGE WAS CONFIRMED IN ONE (TEGO 1) OF THE SIX SAMPLES RETURNED. THE LEAKING TEGO SAMPLE (1) HAD BEEN DAMAGED ON THE ONE PIECE SEAL AT THE POST SEAL INTERFACE. THE REMAINING D1000 TEGO SAMPLES MET PRESSURE PERFORMANCE EXPECTATIONS OUTLINED IN THE PRODUCT SPECIFICATION. IT IS UNKNOWN HOW THE TEGO TOP SURFACE SEAL TEARING OCCURRED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING DAMAGED COMPONENT/LEAKAGE ISSUES WITH USE OF UNSPECIFIED DIALYSIS SET-UPS WHERE D1000 TEGO CONNECTORS WERE IN USE. THE INITIAL INFORMATION RECEIVED REPORTS MULTIPLE EVENTS ((B)(6) 2016) WHERE DURING DIALYSIS SESSIONS, ATTENDING CLINICIANS WERE REMOVING/REPLACING TEGO CONNECTORS DUE TO "BLOOD LEAKAGES AND TORN MEMBRANES". THIS WAS OCCURRING DURING FIRST SESSION AND SECOND SESSIONS. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646365 TEGO TEGO FPA ICU MEDICAL, INC. D1000 3251288

    Patients

    Seq Age Sex Outcome Treatment
    1