BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC MONITORING KIT

    MDR report key: 6120154 · Received November 22, 2016

    Report

    Report Number
    2025816-2016-00252
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    September 21, 2016
    Report Date
    December 30, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3242261 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN 05/2016 CITING NO EXCEPTION DOCUMENTS.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3242261 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN 05/2016 CITING NO EXCEPTION DOCUMENTS. VISUAL RECEIPT: 12/21/2016 - RECEIVED ONE USED 011-42584-05, TRANSPAC IV MONITORING KIT, REPORTED LOT# 3242261. THE PRESSURE TUBING WAS OBSERVED TO BE CRACKED AT THE BONDING SITE OF THE MALE LUER CONNECTED TO THE STOPCOCK. FUNCTIONAL TESTING: UNIT WAS VISUALLY EXAMINED. THE TUBING WAS OBSERVED TO BE CRACK FROM THE 48" TUBING ATTACHED TO THE MALE LUER CONNECTED TO THE STOPCOCK. FINAL ANALYSIS SUMMARY: THE REPORTED COMPLAINT OF "TUBING BROKEN" WAS CONFIRMED. ICU THROUGH CONTINUOUS CORRECTIVE AND PREVENTATIVE ACTIONS ARE REVIEWING THE PROCESS AND MAKING THE NECESSARY IMPROVEMENTS TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 011-42584-05, TRANSPAC IV MONITORING KIT, LOT# 3242261 (MFD. 05/2016). REPORT STATES: TUBING BROKEN. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 011-42584-05, TRANSPAC IV MONITORING KIT, LOT# 3242261 (MFD. 05/2016). REPORT STATES: TUBING BROKEN. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772502 TRANSPAC MONITORING KIT TRANSPAC DRS ICU MEDICAL, INC. 011-42584-05 3242261

    Patients

    Seq Age Sex Outcome Treatment
    1