BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGO CONNECTOR

    MDR report key: 3151874 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00054
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    July 17, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION: VISUAL ANALYSIS OF THE RETURNED "AS-RECEIVED" TEGO CONNECTOR IDENTIFIED THE CONNECTOR WAS PARTIALLY OCCLUDED. DURING DECONTAMINATION FLUSHING A LARGE CLOT WAS DISCHARGED. NO OTHER OBVIOUS ABNORMALITIES WERE VISUALLY OBSERVED. MANUFACTURER'S INVESTIGATION FUNCTIONAL AND PERFORMANCE TESTING TO THE APPLICABLE TEGO PRODUCT SPECIFICATIONS INCLUDING FLUID FLOW; POSITIVE PRESSURE (NOT ACTIVATED) LEAK TESTING; ACTIVATED HIGH PRESSURE LEAK TESTING; NEGATIVE PRESSURE (UNCAPPED); NEGATIVE PRESSURE (CAPPED) LEAK TESTING AND EXTENDED LOW PRESSURE LEAK TESTING WERE PERFORMED. THE RESULTS RECORDED THE RETURNED D100 DEVICE MET THE APPLICABLE PERFORMANCE REQUIREMENTS AND SPECIFICATIONS. THERE WERE NO LEAKAGES OR FLOW ISSUES REPLICATED. LOT BUILD RECORD REVIEW: A REVIEW OF THE MANUFACTURING LOT DATABASE FOR THE REPORTED LOT NUMBER 2482518 (MFG DATE 04/01/2012) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MANUFACTURING BUILD. CONCLUSION: THOROUGH TESTING OF THE ONE RETURNED USED D1000 TEGO CONNECTOR RECORDED NO FUNCTIONAL AND OR PERFORMANCE ISSUES. THE EXACT CAUSE(S) OF THE REPORTED EVENTS ARE UNK. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN PROVIDED TO THE REPORTING HEALTHCARE PROVIDER FOR THEIR REVIEW AND UNDERSTANDING.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED CONCERNING LEAKAGE PROBLEMS WITH USE OF D1000 TEGO CONNECTORS AND UNK DIALYSIS CATHETER/DIALYSIS TUBING LINES. IT WAS REPORTED THAT OVER A THREE MONTH PERIOD OF TIME LEAKAGE PROBLEMS WERE ENCOUNTERED WITH TWO DIFFERENT HOMECARE PATIENTS. THE REPORT ALSO DESCRIBES WHAT APPEARS TO BE CATHETER CLAMPING/FLUSHING AND ATTACHMENT RELATED USAGE ISSUES THAT MAY HAVE CONTRIBUTED TO THE EVENTS. THE MEDSUN REPORT ALSO CONFIRMS THAT FOLLOWING THE INCIDENTS, PATIENTS EXPERIENCED NO ADVERSE CONSEQUENCES OR REQUIRED ANY TYPE OF MEDICAL TREATMENTS. DEVICE RETURN: ONLY ONE (1) USED D1000 TEGO CONNECTOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND INVESTIGATION. ALTHOUGH RETURN WAS REQUESTED, THE SET-UP/MATING DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221587 TEGO CONNECTOR TEGO FPA ICU MEDICAL, INC. D1000 2482518

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR DIALYSIS TUBING LINES| UNKNOWN HEMODIALYSIS CATHETERS