BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS CONNECTOR

    MDR report key: 5248789 · Received November 25, 2015

    Report

    Report Number
    2025816-2015-00137
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    October 6, 2015
    Report Date
    October 21, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING ANALYSIS: THE FOUR USED 011-H2457 SPIROS CONNECTORS WERE EXAMINED MICROSCOPICALLY AND FOUND TO HAVE EITHER EVIDENCE OF PRIOR BINDING IN THE GATE WELL OR HAVING THE SHEAR TAB RESIDENT IN THE GATE WELL. THIS CONDITION WOULD COMPROMISE THE SPIN FEATURE, IN THAT ANY ROTATION IN THE DISCONNECT DIRECTION COULD RESULT IN A PREMATURE DISCONNECT FROM A LUER LOCK SYRINGE. MFG. LOT BUILD RECORD REVIEW: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 3061416 (MFG. DATE 06/2015) SHOWS (B)(4) UNITS WERE MFG. TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: ENGINEERING ANALYSIS OF THE FOUR RETURNED DEVICES CONFIRMED THE REPORTED PRODUCT ISSUE. THE ROOT CAUSE WAS DETERMINED TO BE ATTRIBUTABLE TO THE MFG./ASSEMBLY PROCESS. A MULTI DISCIPLINE CONTINUOUS IMPROVEMENT TEAM WAS FORMED TO FURTHER INVESTIGATE AND PERFORM IN-DEPTH ANALYSIS OF THIS TYPE OF INTERMITTENT ASSEMBLY ISSUES. A REVIEW OF THE APPLICABLE DESIGN, MATERIALS, AND INVOLVED MANUFACTURING AND EQUIPMENT PROCESSES WAS CONDUCTED. THE CONTINUOUS IMPROVEMENT TEAM IDENTIFIED EQUIPMENT/TOOLING ENHANCEMENTS FOCUSING ON THE GATE AREA OF THE POST COMPONENT. THIS ENHANCEMENT ADDRESSES THE CONTRIBUTORS THAT ARE DERIVED FROM THE PART AND MINIMIZE THE CONTRIBUTIONS THAT ARE CAUSED BY USER, ENVIRONMENT AND MEASUREMENT. THESE ENHANCEMENTS HAVE BEEN VALIDATED, QUALIFIED AND IMPLEMENTED.

    Description of Event or Problem · 1

    INTL (B)(6) COMPLAINT RECEIVED CONCERNING DISCONNECT/LEAKAGE ISSUES WITH USE OF 011-H2457, SPIROS CLOSED MALE LUER (MULTI-PACK). IT WAS REPORTED THAT ".. SEPARATION OF THE SPIROS FIXED ON THE SYRINGE...CHEMOTHERAPY PRODUCT LEAK DUE TO BREAK BETWEEN SPIROS AND SYRINGE. CHEMICAL CONTAMINATION .. CLOSED SYSTEM FAULTY ..LOSS OF PRODUCT .. LOSS OF TIME". THERE WERE NO REPORTED ADVERSE PATIENT/OPERATOR CONSEQUENCES. DEVICE RETURN: FOUR (4) USED SPIROS CONNECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782015 SPIROS CONNECTOR SPIROS CONNECTOR FPA ICU MEDICAL, INC. 011-H2457 3061416

    Patients

    Seq Age Sex Outcome Treatment
    1