BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE

    MDR report key: 5510763 · Received March 18, 2016

    Report

    Report Number
    2025816-2016-00021
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    March 23, 2016
    Report Date
    March 18, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K970855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS: 3/11/2016 - RECEIVED THE FOLLOWING DEVICES: EIGHT (8) NEW MC100 MICROCLAVE CLEAR CONNECTORS LOT# 3190625. ONE (1) NEW CADD ADMINISTRATION SET SMITHS MEDICAL REF# (B)(4), SIX (6) NEW POWER LOC MAX REF (B)(4). FUNCTIONAL TESTING: EACH OF THE POWER LOC MAX, MC100 MICROCLAVE CLEAR CONNECTORS, AND CADD ADMINISTRATION SET LUERS WERE MEASURED AND ALL WERE FOUND TO BE ISO COMPLIANT. EACH OF THE NEW POWER LOC MAX WERE CONNECTED TO A NEW MC100 MICROCLAVE AND PRESSURE LEAK TESTED AT 45PSI. NO LEAKAGE WAS OBSERVED AT ANY OF THE CONNECTIONS AND THERE WAS NO PROPENSITY TO DISCONNECT. THE NEW CADD ADMINISTRATION SET WAS CONNECTED TO A NEW MC100 MICROCLAVE AND PRESSURE LEAK TESTED AT 45PSI. NO LEAKAGE WAS OBSERVED AND THERE WAS NO PROPENSITY TO DISCONNECT. DIMENSIONAL ANALYSIS: MC100 MICROCLAVE CLEAR CONNECTORS. ISO MALE LUER TAPER: PASS (ALL EIGHT). POWER LOC MAX . ISO FEMALE LUER TAPER: PASS (ALL SIX). CADD ADMINISTRATION SET. ISO MALE LUER TAPER: PASS. ANALYSIS SUMMARY: THE COMPLAINT OF DISCONNECT AND SUBSEQUENT LEAKAGE BETWEEN THE POWER LOC MAX PORT HUB AND THE MC100 MICROCLAVE WAS UNABLE TO BE CONFIRMED OR REPLICATED. THE NEW AND UNUSED SAMPLES RETURNED WERE MEASURED, CONNECTED, AND THEN PRESSURE TESTED. NO LEAKAGE OR DISCONNECTS WERE OBSERVED DURING THE TESTING.

    Description of Event or Problem · 1

    REPORT STATES, 9 HOURS AFTER HOOKUP. IT CAME APART AT PORT HUB AND INJECTION CAP. ENDED UP GOING TO ED SINCE HE WAS DRIVING BY. WE THEN ENDED UP REMIXING A BAG AND RESTARTING THE NEXT DAY. THERE WAS SOME DELAY IN TIME, BUT NO EXPECTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166127 MICROCLAVE MICROCLAVE FPA ICU MEDICAL, INC. MC100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1