BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8" EXT. SET

    MDR report key: 5580930 · Received April 15, 2016

    Report

    Report Number
    2025816-2016-00033
    Event Type
    Malfunction
    Date Received
    April 15, 2016
    Date of Event
    March 11, 2016
    Report Date
    April 15, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K941190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL RECEIPT ANALYSIS: 4/7/2016 - RECEIVED ONE (1) USED 081-C4203-2, 8.5" (22CM) APPX 1.1ML EXT SET W/2 CLAVE, CLAMP, ROTATING LUER; LOT# 3060049. NO MATING DEVICES WERE RETURNED. THE SILICONE SEAL WAS COMPLETELY SEPARATED FROM THE MICROCLAVE HOUSING. FUNCTIONAL TESTING: CORING WAS OBSERVED ON THE SILICONE SEAL. UNIT WAS DISASSEMBLED AND THEN PUT BACK TOGETHER. UNIT WAS PRESSURE TESTED. NO LEAKING WAS OBSERVED IN THE ACTIVATED OR UNACTIVATED STATE. ANALYSIS SUMMARY: THE REPORTED COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. PREVIOUS ENGINEERING ANALYSIS HAS SHOWN THAT EXCESSIVE BACKPRESSURE CAN CAUSE THE SILICONE PLUG TO DISLODGE FROM THE MICROCLAVE. THE CORING OBSERVED IS INDICATIVE OF AN INCOMPATABLE MATING DEVICE.

    Description of Event or Problem · 1

    COMPLAINT REC'D REGARDING ONE (1) 081-C4203-2, 8.5" (22CM) APPX 1.1ML EXT SET W/2 CLAVE, CLAMP, ROTATING LUER; LOT# 3060049. THE REPORT STATES, THE RECESSED SILICONE PLUG WAS FOUND WHEN A USER DISCONNECTED A INFUSION SET (NIPRO'S EX2-100NFX AND ISA-200D002) FROM CLAVE CONNECTOR AFTER ADMINISTRATION OF ANTIBIOTIC FOR AN HOUR. DURATION OF USE: FOR A FEW DAYS (LESS THAN A WEEK). THERE WERE NO ADVERSE OPERATOR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236646 8" EXT. SET 8" EXT. SET FPA ICU MEDICAL, INC. 081-C4203-2 3060049

    Patients

    Seq Age Sex Outcome Treatment
    1