BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIFUSE EXTENTION SET

    MDR report key: 6371535 · Received March 2, 2017

    Report

    Report Number
    2025816-2017-00048
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    January 16, 2017
    Report Date
    March 31, 2017
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/SIMILAR PROBLEM DID RECORD ADDITIONAL REPORTS AND INVESTIGATIONS. A REVIEW OF THOSE INVESTIGATIONS WHERE DEVICES WERE RETURNED RECORDED MIXED RESULTS, INCLUDING NO DEFECT FOUND; USAGE; CANNOT DETERMINE AND MFG./ DESIGN. VISUAL ANALYSIS: 3/16/2017 - RECEIVED ONE USED 011-H1836, 13 CM (5") APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, ROTATING LUER LOCK, LOT# UNKNOWN. NO MATING DEVICES WERE RETURNED. FUNCTIONAL TESTING: MICROSCOPIC EXAMINATION REVEALED TEARING ON THE SILICONE SEAL TOP SURFACE OF ONE OF THE TWO MICROCLAVE CONNECTORS ASSEMBLED INTO THE 011-H1836 EXTENSION SET. THE TEARING EXTENDED TO THE EDGE OF THE SILICONE SEAL COMPROMISING THE DYNAMIC SEAL BETWEEN THE MATING DEVICE AND THE MICROCLAVE CONNECTOR. ANALYSIS SUMMARY: THE COMPLAINT OF 011-H1836 EXTENSION SET LEAKAGE WAS CONFIRMED. THE LEAKAGE WAS DUE TO DAMAGE SUSTAINED TO THE MICROCLAVE DURING USE. THIS TYPE OF MICROCLAVE DAMAGE IS TYPICAL OF ACCESS WITH AN INCOMPATIBLE MATING DEVICE. NO MATING DEVICES WERE RETURNED TO EVALUATE WITH THE 011-H1836 EXTENSION SET. THE MICROCLAVE CONNECTOR SHOULD ONLY BE ACCESSED WITH AN ISO COMPLIANT MALE LUER WITH AN INSIDE DIAMETER BETWEEN 0.062" AND 0.110". ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING AND UNSPECIFIED QUANTITY OF 011-H1836, 13 CM (5") APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, ROTATING LUER LOCK, LOT # UNKNOWN. REPORT STATES: DURING INFUSION OF NORADRENALIN THROUGH A VYGON MANOMETER, LINE LEAKAGE OF THE DRUG WAS NOTICED FROM THE MICROCLAVE. THE LEAKAGE WAS NOTED AT THE JUNCTION BETWEEN THE BLUE HOUSING AND THE CLEAR CONNECTION OF THE MICROCLAVE. THIS IS THE SAME FOR EACH ITEM BEING REPORTED AND WAS RECTIFIED EACH TIME BY REPLACING THE MICROCLAVE, LINE AND SYRINGE. THE PATIENT HAD A DELAY IN DELIVERY OF THE DRUG BUT NO ADVERSE CLINICAL CHANGE IN THE PATIENT AS A RESULT OF THE DELAY.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING AND UNSPECIFIED QUANTITY OF 011-H1836, 13 CM (5") APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, ROTATING LUER LOCK, LOT# UNKNOWN. REPORT STATES: DURING INFUSION OF NORADRENALIN THOUGH A VYGON MANOMETER, LINE LEAKAGE OF THE DRUG WAS NOTICED FROM THE MICROCLAVE. THE LEAKAGE WAS NOTED AT THE JUNCTION BETWEEN THE BLUE HOUSING AND THE CLEAR CONNECTION OF THE MICROCLAVE. THIS IS THE SAME FOR EACH ITEM BEING REPORTED AND WAS RECTIFIED EACH TIME BY REPLACING THE MICROCLAVE, LINE AND SYRINGE. THE PATIENT HAD A DELAY IN DELIVERY OF THE DRUG BUT NO ADVERSE CLINICAL CHANGE IN THE PATIENT AS A RESULT OF THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157291 BIFUSE EXTENTION SET BIFUSE EXTENTION SET FMG ICU MEDICAL, INC. 011-H1836 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1