BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADD-ON SET

    MDR report key: 5949213 · Received September 14, 2016

    Report

    Report Number
    2025816-2016-00137
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Date of Event
    August 3, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3202211 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MARCH 2016, CITING NO ANOMALIES. INCOMING VISUAL: 10/5/2016 - RECEIVED ON 8/31/2016 ONE CH3033, 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS W/RED CAP AND VENTED CAP, REPORTED LOT# 3202211. ONE USED BAXTER 100ML SALINE BAG. TWO SMALL CUTS WERE OBSERVED IN THE BAG SPIKE ADAPTER OF THE CH3033. FUNCTIONAL TESTING: THE CH3033 DEVICE WAS LEAK TESTED WITH WATER AND LEAKS OCCURRED FROM THE NICKS (HOLES) IN THE ADD-ON TUBING AT GRAVITY PRESSURE (1.5 PSIG). ANALYSIS SUMMARY: THE REPORTED PRODUCT PROBLEM FOR A HOLE IN THE ADD-ON TUBING WAS CONFIRMED. THE PROBLEM DID APPEAR TO BE CAUSED BY THE SPIKE OF A DRIP CHAMBER DURING INSERTION INTO THE TUBING.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3202211 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MARCH 2016, CITING NO ANOMALIES.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE CH3033, 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS W/RED CAP AND VENTED CAP, LOT# 3202211 (MFD. 03/2016). REPORT STATES; HOLE FOUND IN THE INFUSION TUBING, THE PERFORATED AREA IS LOCATED AT THE LOCATION OF THE CLAMP MOVED UP. NO SERIOUS PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE CH3033, 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS W/RED CAP AND VENTED CAP, LOT# 3202211 (MFD. 03/2016). REPORT STATES; HOLE FOUND IN THE INFUSION TUBING, THE PERFORATED AREA IS LOCATED AT THE LOCATION OF THE CLAMP MOVED UP. NO SERIOUS PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602469 ADD-ON SET ADDON-SET FMG ICU MEDICAL, INC. CH3033 3202211

    Patients

    Seq Age Sex Outcome Treatment
    1