BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESET TRANSPAC IT

    MDR report key: 5226047 · Received November 16, 2015

    Report

    Report Number
    2025816-2015-00125
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    September 1, 2015
    Report Date
    November 6, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K052828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AS RECEIVED PARTIAL SUBASSEMBLIES OF TWO USED 011-46103-05 SAFESET TRANSPAC IV MTG. KITS, CONFIRMED THE DISCONNECTIONS. ENGINEERING ANALYSIS: PARTIAL COMPLAINT SAMPLE CONFIRMED THE REPORTED BONDING ISSUE. 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

    INTERNATIONAL (B)(6) COMPLAINT RECEIVED REPORTING COMPONENT SEPARATION/LEAKAGE ISSUES WITH USE OF 011-46103-05 SAFESET TRANSPAC IV MTG. KITS. THE INITIAL INFORMATION RECEIVED REPORTS DURING AUG - SEPT THERE HAVE BEEN FIVE INCIDENTS WHERE THE "... BONDING OF THE PRESSURE TUBING TO THE LAS COMING APART. ..TWO CASES OCCURRED DURING INFUSION AND WHEN ON THE PATIENT. UNFORTUNATELY THE PATIENTS LOST BLOOD AS THE SEPARATION OF THE PRESSURE TUBING FROM THE MALE CONNECTOR WAS NOT DETECTED STRAIGHT AWAY...". THREE ADDITIONAL INCIDENTS OF SEPARATION OF THE PRESSURE TUBING FROM THE MALE LUER HAVE BEEN NOTED... THE BONDING ISSUE APPEARS TO BE AN ONGOING SCENARIO ..." TWO "PARTIAL" 011-46103-05 MTG KITS ARE BEING RETURNED. FOLLOW UP IN PROGRESS - CONFIRMATION REQUIRED REGARDING PATIENT BLOOD LOSS/CLINICALLY SIGNIFICANT. IT WAS REPORTED THAT PATIENTS RETURNED TO BASELINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755403 SAFESET TRANSPAC IT TRANSPAC DRS ICU MEDICAL, INC. 011-46103-05 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1