BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT. SET

    MDR report key: 5821922 · Received July 26, 2016

    Report

    Report Number
    2025816-2016-00082
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 30, 2016
    Report Date
    August 25, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT LOT# REVIEW: A REVIEW OF LOT# 3200413 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN FEBRUARY 2016 CITING NO ANOMALIES. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    SUSPECT LOT# REVIEW: A REVIEW OF LOT# 3200413 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN FEBRUARY 2016 CITING NO ANOMALIES. RECEIPT ANALYSIS: 7/28/2016 - RECEIVED ONE 011-CH3569, 169CM PUR YELLOW SMALLBORE EXT. SET W/NANOCLAVE 4-WAY STOPCOCK, ROTATING LUER W/FILTER CAP AND DROP-IN SPIROS, SUSPECT LOT# 3200413. A LEAK WAS OBSERVED AT THE BONDING SITE OF THE MALE LUER FROM THE STOPCOCK AND THE FEMALE LUER OF THE YELLOW TUBING. FUNCTIONAL/PERFORMANCE TESTING: THE 011-CH3569 DEVICE WAS PRIMED WITH WATER AND THEN LEAK TESTED. WATER LEAKED AT THE BONDED CONNECTION BETWEEN THE WINGLESS FEMALE LUER AND THE STOPCOCK AT 4 PSIG. ANALYSIS SUMMARY: THE REPORTED PRODUCT PROBLEM FOR LEAKAGE WAS CONFIRMED. THE LEAKAGE WAS FOUND AT THE WINGLESS FEMALE LUER/STOPCOCK BOND. THERE IS A CHANNEL LEAK AT THE BONDED CONNECTION. THE BONDING METHOD/APPLICATION WAS ANALYZED AND HAS BEEN IMPROVED/IMPLEMENTATED AUGUST 2016.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 011-CH3589, 169CM PUR YELLOW SMALLBORE EXT. SET W/NANOCLAVE 4-WAY STOPCOCK, ROTATING LUER W/FILTER CAP AND DROP-IN SPIROS, SUSPECT LOT# 3200413 (MFD. 02/2016). REPORT STATES; "DURING INFUSION, CHEMOTHERAPY BEGAN TO SINK TO THE LEVEL OF A CONNECTION." UNPROTECTED CHEMO EXPOSURE REPORTED BUT CLEANED PER HOSPITAL PROTOCOL. NO SERIOUS ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 011-CH3589, 169CM PUR YELLOW SMALLBORE EXT. SET W/NANOCLAVE 4-WAY STOPCOCK, ROTATING LUER W/FILTER CAP AND DROP-IN SPIROS, SUSPECT LOT# 3200413 (MFD. 02/2016). REPORT STATES; "DURING INFUSION, CHEMOTHERAPY BEGAN TO SINK TO THE LEVEL OF A CONNECTION." UNPROTECTED CHEMO EXPOSURE REPORTED BUT CLEANED PER HOSPITAL PROTOCOL. NO SERIOUS ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475516 EXT. SET EXT. SET FPA ICU MEDICAL, INC. 011-CH3569 3200413 (SUSPECT)

    Patients

    Seq Age Sex Outcome Treatment
    1