BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGO

    MDR report key: 3252642 · Received July 18, 2013

    Report

    Report Number
    2025816-2013-00057
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFRS INVESTIGATION: (B)(4). THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG BUILD CYCLES. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/LOT# RECORDED NO ADD¿L REPORTS. CONCLUSION: THE INVOLVED TEGO CONNECTOR AND MATING DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE OF THE PROBLEM IS UNK. THIS COMPLAINT AND ASSOCIATED INFO HAVE BEEN ENTERED IN THE MFRS DATABASE FOR ANALYSIS AND TRENDING.

    Description of Event or Problem · 1

    INT¿L (B)(6) COMPLAINT REC¿D REPORTING LEAKAGE ISSUE WITH USE OF D1000 TEGO CONNECTOR. IT WAS REPORTED THAT ¿PT HAD DIALYSIS, LEFT UNIT, RETURNED AN HR LATER WITH BLOOD COMING OUT END OF TEGO¿¿. THE TEGO WAS REMOVED, REPLACED AND HAS BEEN DISCARDED. BLOOD LOSS REPORTED EST. 5ML ¿ 10ML.¿ THERE WAS NO REPORTED ADVERSE PT CONSEQUENCES. ALTHOUGH RETURN OF SAME LOT SAMPLES WAS REQUESTED, AS OF THE DATE OF THIS REPORT NO DEVICES WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335271 TEGO CONNECTOR FPA ICU MEDICAL INC. D1000 2576731

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIFELINE BETA| POSIFLUSH SP SYRINGE| FRESENIUS TUBING| BD 3CC/10CC SYRINGE| AV-SET ONLINE PLUS BVM 5008-R