BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5" (16.5 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET

    MDR report key: 6152745 · Received December 7, 2016

    Report

    Report Number
    2025816-2016-00266
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K100576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF THE COMPLAINT DATABASE SHOWED NO OTHER COMPLAINTS OF THIS NATURE RECORDED. VISUAL RECEIPT ANALYSIS: ONE USED A1099, 6.5" (16.5 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE CLEAR, NANOCLAVE T-CONNECTOR, PURPLE CLAMP, ROTATING LUER; REPORTED LOT# 3243606. ONE OPENED A1099, 6.5" (16.5 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE CLEAR, NANOCLAVE T-CONNECTOR, PURPLE CLAMP, ROTATING LUER; REPORTED LOT# 3243606. ONE USED PICC. THE USED A1099 DEVICE HAD THE SILICONE SEAL PROTRUDING FROM THE NANO T-CONNECTOR. THE UNUSED DEVICE HAD NO VISIBLE ANOMALIES PRESENT. THE PICC WAS CONNECTED TO THE A1099A, BLOOD WAS OBSERVED IN THE FLUID PATH. THE SILICONE SEAL OF THE NANOCLAVE WAS PROTRUDING FROM THE HOUSING. FUNCTIONAL TESTING: THE UNUSED A1099 DEVICE WAS LEAK TESTED WITH WATER AT 45 PSIG FOR 1 MINUTE WITH BOTH OF THE NANO T-CONNECTOR AND THE MICROCLAVE IN THE INACTIVATED POSITIONS. NO LEAKS WERE FOUND AND THE SILICONE SEALS DID NOT PROTRUDE. FINAL ANALYSIS SUMMARY: THE REPORTED COMPLAINT FOR SILICONE SEAL PROTRUDING FROM THE NANO T-CONNECTOR WAS CONFIRMED ON ONE OF THE RETURNED DEVICES. SILICONE SEAL PROTRUSIONS OF THIS NATURE CAN OCCUR WHEN THE NANO OR MICROCLAVE ASSEMBLY IS EXPOSED TO HIGH BACK PRESSURES. HIGH PRESSURES CAN BE GENERATED WITH SMALL SYRINGES (10CC AND SMALLER). THE FLUSHING OF THE DEVICE SHOULD ONLY OCCUR AT THE NANO T CONNECTOR WHILE THE CLAMP ON THE MICROCLAVE LINE IS ACTIVATED (CLAMPED). THE CLAMP WILL ISOLATE THE MICROCLAVE LINE AND PREVENT THE SILICONE SEAL FROM PROTRUDING.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING AN A1099, 6.5" (16.5 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, NANOCLAVE® T-CONNECTOR, PURPLE CLAMP, ROTATING LUER, LOT# IS UNKNOWN. REPORT STATES: RN WENT TO FLUSH SAFETY CARE AND NOTED LEAKING FROM NANOCLAVE ON EXTENSION. UPON INVESTIGATION SHE FOUND RUBBER/SPRING POPPED OUT OF THE TOP. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ON A1099, 6.5" (16.5 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, NANOCLAVE® T-CONNECTOR, PURPLE CLAMP, ROTATING LUER, LOT# IS UNKNOWN. REPORT STATES: RN WENT TO FLUSH SAFETY CARE AND NOTED LEAKING FROM NANOCLAVE ON EXTENSION. UPON INVESTIGATION SHE FOUND RUBBER/SPRING POPPED OUT OF THE TOP. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801851 6.5" (16.5 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET 6.5" (16.5 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET FPA ICU MEDICAL, INC. A1099 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1