BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV TRIFURCATED MONITORING KIT

    MDR report key: 5205375 · Received November 5, 2015

    Report

    Report Number
    2025816-2015-00121
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    October 5, 2015
    Report Date
    November 5, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: LOT NUMBER 3046600 SHOWED (B)(4) EACH WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED WITH NO ANOMALIES IN 06/2015. ENGINEERING ANALYSIS: PARTIAL COMPLAINT SAMPLE CONFIRMED THE REPORTED DISCONNECTION PROBLEM. THE ROOT CAUSE WAS ATTRIBUTABLE TO AN ISOLATED MANUFACTURING ASSEMBLY ERROR WHERE THERE WAS AN INSUFFICIENT SEAL BETWEEN THE TUBING AND THE MATING COMPONENTRY. A REVIEW OF THE APPLICABLE DESIGN, MATERIALS AND INVOLVED MANUFACTURING/EQUIPMENT PROCESSES WAS CONDUCTED. DETAILED REVIEWS OF PREVIOUSLY IMPLEMENTED IMPROVEMENTS RELATING TO ASSEMBLY BONDING OPERATIONS, EQUIPMENT AND EMPLOYEE TRAINING PROGRAMS WERE PERFORMED. ACTION: THE INITIAL ENGINEERING EFFORTS "QND" TEAM INVESTIGATIONS OF THIS COMPONENT ASSEMBLY BONDING PROCESSES RECORDED MIXED FINDINGS THAT WERE INCONCLUSIVE. ADDITIONAL INVESTIGATION ACTIVITIES AND ENGINEERING EFFORTS ARE IN PROGRESS. A MULTI-DISCIPLINE CONTINUOUS IMPROVEMENT TEAM HAS BEEN FORMED TO REVIEW AND CHALLENGE THE APPLICABLE DESIGN, MATERIALS, AND INVOLVED MANUFACTURING /EQUIPMENT PROCESSES. AS AN INTERIM MEASURE HEIGHTENED INSPECTIONS HAVE BEEN INITIATED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FOR 46112-05, TRANSPAC IV TRIFURCATED MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, ARTEROA; SAFESET RESERVOIR AND NEEDLELESS VALVES, LOT NUMBER 3046600 (MFG'D 06/2015). REPORT STATES "SPONTANEOUS DISENGAGEMENT OF PRESSURE TUBING FROM THE LUER JUST DISTAL THE ZEROING STOPCOCK." NO SERIOUS ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733765 TRANSPAC IV TRIFURCATED MONITORING KIT TRANSPAC DRS ICU MEDICAL, INC. 46112-05 3046600

    Patients

    Seq Age Sex Outcome Treatment
    1