BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFLOW CARTRIDGE

    MDR report key: 1881264 · Received October 6, 2010

    Report

    Report Number
    3006095475-2010-00010
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    May 25, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ENGINIVITY LLC
    Product Code
    LGZ
    PMA / PMN Number
    K060537
    Removal / Correction Number
    3006095475-7/12/10-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REPORTED EVENT IS THAT TWO DIMENSIONS ON THE TAPERED LUER SHAFT WERE OUT OF SPEC. THIS DEVIATION MAKES IT HARD TO SLIDE THE TAPERED LUER SHAFT INTO A MATING LUER CONNECTOR AND TIGHTEN THE LUER LOCK RING FOR A SECURE FIT. DUE TO THE OVERSIZE CONDITION, THE TAPER WILL NOT INSERT AS FAR UP THE SHAFT AS IT WOULD NORMALLY WITHOUT ADDED FORCE. THIS DEVIATION OCCURRED DURING ROUTINE MOLD MAINTENANCE WHILE POLISHING THE MOLD CAVITY. THE POLISHING REMOVED MATERIAL, WHICH INCREASED THE OUTER DIAMETER OF THE PLASTIC LUER CONNECTOR ON THE CARTRIDGE. FIRST ARTICLE INSPECTION AFTER TOOL MAINTENANCE FAILED TO INCLUDE TWO OUTER DIAMETER CRITICAL DIMENSIONS ON THE INSPECTION (OUTER DIAMETER IS TAPERED). TOOLING WAS RELEASED WITHOUT VERIFICATION OF THESE TWO DIMENSIONS. THIS ISSUE WAS REPORTED TO FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER FACILITY WAS ALLEGEDLY UNABLE TO ATTACH TUBING TO THE CARTRIDGE. THE EXTENSION SET REPORTEDLY CAME OFF OF THE ENFLOW CARTRIDGE AND BLOOD WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENFLOW CARTRIDGE WARMER, THERMAL, INFUSION FLUID LGZ ENGINIVITY LLC 980200 1011004

    Patients

    Seq Age Sex Outcome Treatment
    1