BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CONNECTOR

    MDR report key: 19554760 · Received June 17, 2024

    Report

    Report Number
    2025816-2014-00162
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ICU MEDICAL INC
    Product Code
    FPA
    UDI-DI
    00840619023386
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL ENGINEERING ANALYSIS OF THE 20130-01 SPINNING SPIROS WAS PERFORMED. THE SPINNING SPIROS WAS TESTED PER THE APPLICABLE PRODUCT SPECIFICATION. THE RESULTS RECORDED A INTERNAL LEAK. UNDER MICROSCOPIC OBSERVATION IT WAS FOUND THAT THE DEVICE O-RING COMPONENT WAS MISSING. THIS CONDITION CAUSED THE INTERNAL LEAKAGE. FINDINGS: ENGINEERING EVALUATION OF THE RETURNED DEVICES CONFIRMED THE 20130-01 SPINNING SPIROS WAS MANUFACTURED INCORRECTLY. DETAILED ANALYSIS OF THE INVOLVED COMPONENT MANUFACTURING AND ASSEMBLY PROCESSES WHICH INCLUDED EQUIPMENT, INSPECTIONS AND WORK INSTRUCTIONS WAS PERFORMED. THE TEAM IDENTIFIED SEVERAL IMPROVEMENTS FOCUSING ON THE PRESS, TEST OPERATIONS AND WELDER STATION PROCESSING SEQUENCES. THE AUTOMATED ASSEMBLY PROCESS NOW HAS A SENSOR THAT 100% VERIFIES THE PRESENCE AND PROPER PLACEMENT OF THE COMPONENTRY (O-RING ON THE FEMALE LUER). THE WORK FLOWS WERE MODIFIED, ADDITIONAL DETAILED ASSEMBLY INSTRUCTIONS WERE IMPLEMENTED AND AFFECTED EMPLOYEE TRAINING WAS PERFORMED.

    Description of Event or Problem · 0

    COMPLAINT RECEIVED REPORTING OCCLUSION/EXTRACTION DIFFICULTIES WITH SET-UP CONSISTING OF ONE (1) 20130-01 SPINNING SPIROS; SYRINGE; VIAL ADAPTOR. IT WAS REPORTED THAT " TECHNICIAN WAS UNABLE TO WITHDRAW DRUG FROM VIAL ADAPTER. THE SYRINGE-SPIROS COMBINATION SEEMS TO JUST DRAW AIR, AND NOT ALLOW DRUG TO BE PULLED UP THROUGH THE SYRINGE". THERE WAS NO PATIENT INVOLVEMENT OR ANY REPORTED ADVERSE OPERATOR CONSEQUENCES. DEVICE RETURN: ONE USED 20130-01 SPINNING SPIROS ATTACHED TO A 10ML BD SYRINGE; GENIE VIAL ADAPTOR ATTACHED TO VIAL OF DACOGEN. ENGINEERING TESTING AND ANALYSIS OF THE RETURNED SET-UP WAS PERFORMED. THE RESULTS RECORDED NO FUNCTIONAL OR PERFORMANCE ISSUES WITH THE RETURNED GENIE VIAL ADAPTOR. INITIAL EVALUATION OF THE 10ML SYRINGE - MATED TO THE 20130-01 SPINNING SPIROS DOCUMENTS THAT WHEN ACCESSED WOULD ONLY DRAW AIR, THUS CONFIRMING THE REPORTED PRODUCT ISSUE. CONT. SECTION H.10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650754 SPINNING SPIROS CONNECTOR CONNECTOR FPA ICU MEDICAL INC 20130-01 23-064-Y1 00840619023386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 10ML BD SYRINGE' GENIE VIAL ADAPTOR.| DACOGEN VIAL.