BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS, SPINNING CONNECTOR

    MDR report key: 3381300 · Received September 3, 2013

    Report

    Report Number
    2025816-2013-00102
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    January 1, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: VISUAL ANALYSIS AND INSPECTION OF THE RETURNED USED/PACKAGED DEVICES RECORDED NO OBVIOUS ABNORMALITIES. THE USED 20130-01 SPIROS SPINNING FEATURE WAS ACTIVATED. DIMENSIONAL ANALYSIS OF THE APPLICABLE DEVICE MATING LUER/LUER THREAD COMPONENTS WAS PERFORMED TO THE ISO SPECIFICATIONS. THE RESULTS RECORDED THE RETURNED USED 20130-01 SPIROS AND FOURTEEN OF THE SIXTEEN PACKAGED SAME LOT SAMPLES MET THE SPECIFICATIONS. CODE 100 TWO OF THE RETURNED 20130-01 CONNECTORS DID NOT FULLY MEET THE ISO FEMALE LUER SPECIFICATION. ENGINEERING EVAL OF THIS DEVIATION IDENTIFIED A SMALL RING AT THE OPENING OF THE FEMALE LUER WHICH POTENTIALLY COULD ALTER LUER ENGAGEMENT. THE FOUR RETURNED PACKAGED SYRINGE DEVICE MATING MALE LUERS WERE ALSO MEASURED/EVALUATED FOR ISO COMPLIANCE. THE RESULTS RECORDED NO OUT OF SPEC CONDITIONS. PERFORMANCE TESTING AND ANALYSIS: THE TWO 20130-01 SPIROS CONNECTORS WHICH EXHIBITED THE LUER ANOMALY WERE TESTED WITH THE RETURNED MCKESSON SYRINGES. AFTER ATTACHING, THE CONNECTION AND RESIDUAL TORQUE VALUES WERE MEASURED, MODERATE BENDING AND TWISTING FORCES WERE APPLIED AS FLUIDS PRESSURIZED FROM THE SYRINGE PLUNGER WERE USED TO TEST FOR LEAKAGES AT THE CONNECTION. THE RESULTS RECORDED NO LEAKAGES, DETACHMENTS WERE REPLICATED. CONCLUSION: ENGINEERING TESTING AND ANALYSIS OF THE RETURNED DEVICES RECORDED NO ATTACHMENT OR LEAKAGE ISSUES REPLICATED IN THE LAB SETTING. THE ANALYSIS DID IDENTIFY A MFG DEVIATION ON TWO OF THE SPIROS CONNECTORS FEMALE LUERS. ALTHOUGH ENGINEERING TESTING WAS UNABLE TO REPLICATE THE REPORTED CONNECTION/LEAKAGE ISSUE, THE FINDINGS DID IDENTIFY A CONDITION THAT COULD POTENTIALLY COMPROMISE A SECURE LUER CONNECTION. BASED ON THE RESULTS OF THE ENGINEERING ANALYSIS/FINDINGS THE INVOLVED OPERATIONS AND QUALITY PROCESS TEAMS HAVE INITIATED HEIGHTENED INSPECTIONS. CONCURRENTLY ASSEMBLY AND INSPECTION PROCESSES ARE BEING REVIEWED TO IDENTIFY AND IMPLEMENT APPROPRIATE MEASURES TO ADDRESS THIS TYPE OF DEVIATION. THE EXACT CAUSE (S) OF THE REPORTED ISSUES ARE UNK.

    Description of Event or Problem · 1

    COMPLAINT REC'D CONCERNING DISCONNECTS/LEAKAGE ISSUES WITH USE OF 20130-01 SPINNING SPIROS CONNECTORS. IT WAS REPORTED THAT OVER A 2+ MONTH PERIOD THERE HAVE BEEN APPROX. FIVE INCIDENTS OF DISCONNECTS/ATTACHMENT ISSUES WITH SPIROS CONNECTORS AND ASSORTED SYRINGES, MATING DEVICES. ONE OF THE INCIDENTS REPORTEDLY OCCURRED DURING PT USE AND WAS DESCRIBED AS FOLLOWS "...HAD A LEAK WITH SPIROS CONNECTING TO A 7-DAY CONTINUOUS INFUSION BAG OF IFEX/MESNA WHICH LEAKED ONTO A PT." PT REPORTEDLY EXPERIENCED NO ADVERSE CONSEQUENCES. DEVICE/RETURN: ONE (1) USED 20130-01 SPIROS; SIXTEEN (16) PACKAGED 20130-01, LOT # 24-740-Y1; FOUR ASST. PACKAGED. MCKESSON SYRINGES WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434937 SPIROS, SPINNING CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 20130-01 24-740-Y1

    Patients

    Seq Age Sex Outcome Treatment
    1 SYRINGE: EXTENSION TUBING SET NOI