BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CONNECTOR

    MDR report key: 19554761 · Received June 17, 2024

    Report

    Report Number
    2025816-2014-00161
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    March 11, 2013
    Report Date
    March 11, 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

    ENGINEERING TESTING AND ANALYSIS CONT. ENGINEERING TESTING OF THE RETURNED USED SPINNING SPIROS CONNECTOR RECORDED A LEAK WAS OBSERVED COMING FROM THE HALF SEAL. THE SPINNING SPIROS WAS DISASSEMBLED AND THE HALF SEAL REMOVED AND EVALUATED. THE REPORT DOCUMENTS THE HALF SEAL DAMAGE WAS THE CAUSE OF THE LEAKAGE. THIS CONDITION/COMPONENT DAMAGE OCCURRED DURING THE MFG. ASSEMBLY PROCESS. FINDINGS: ENGINEERING EVALUATIONS OF THE RETURNED PACKAGED 20130-01 DEVICES RECORDED NO NON-CONFORMANCES AND OR OUT OF SPEC. CONDITIONS. THE LEAKAGE ISSUE WAS CONFIRMED WITH THE RETURNED "USED" SPINNING SPIROS CONNECTOR. THE CAUSE OF THE LEAKAGE WAS DUE TO DAMAGES WITHIN THE INTERNAL COMPONENTRY (HALF SEAL). DETAILED ANALYSIS OF THE INVOLVED COMPONENT MANUFACTURING AND ASSEMBLY PROCESSES WHICH INCLUDED EQUIPMENT, INSPECTIONS AND WORK INSTRUCTIONS WAS PERFORMED. CONT. PG. 3 OTHER REMARKS. THE TEAM IDENTIFIED SEVERAL IMPROVEMENTS FOCUSING ON THE PRESS, TEST OPERATIONS AND WELDER STATION PROCESSING OPERATIONAL 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 LEAKAGE ISSUE WITH USE OF ONE (1) 20130-01 SPINNING SPIROS CONNECTOR. IT WAS REPORTED THAT " TECHNICIAN NOTICED DRUG (CARBOPLATIN) LEAKING FROM THE SPIROS. A SECTION OF PLASTIC SEEMS TO BE MISSING ALTOGETHER FROM THE SPIROS UPON VISUAL INSPECTION". THERE WAS NO PATIENT INVOLVEMENT OR ANY REPORTED ADVERSE OPERATOR CONSEQUENCES. DEVICE RETURN: ONE (1) USED 20130-01 SPINNING SPIROS CONNECTOR ATTACHED TO A 20ML BD SYRINGE CONTAINING CARBOPLATIN AND TWO PACKAGED SPINNING SPIROS CONNECTORS LOT#'S 16-884-SJ AND 16-885-SJ. VISUAL INSPECTION AND ANALYSIS (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE RESULTS RECORDED NO OBVIOUS VISUAL ABNORMALITIES WITH THE UNUSED PACKAGED DEVICES. DURING DECONTAMINATION PRESSURE WAS APPLIED TO THE SYRINGE WHILE THE SPINNING SPIROS WAS NOT ACTIVATED AND LEAKAGE WAS OBSERVED TO COME FROM INSIDE THE DEVICE. ENGINEERING TESTING AND ANALYSIS: THE TWO UNUSED SPINNING SPIROS CONNECTORS WERE PRESSURE LEAK TESTED PER THE APPLICABLE PRODUCT SPECIFICATION. THE RESULTS RECORDED NO PERFORMANCE ISSUES, LEAKAGES AND OR OUT OF SPEC CONDITIONS. CONT. SECTION H.10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650755 SPINNING SPIROS CONNECTOR CONNECTOR FPA ICU MEDICAL INC 20130-01 16-884-SJ 00840619023386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 20ML BD SYRINGE