BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER

    MDR report key: 3262370 · Received July 18, 2013

    Report

    Report Number
    2025816-2013-00070
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION AND ANALYSIS: DEVICE RETURN - ONE (1) USED 20130-01 SPIROS CONNECTED TO 60ML BD SYRINGE AND ONE PACKAGED 20130-01 SPINNING SPIROS, LOT #23-267-SL. ENGINEERING TESTING AND ANALYSIS OF THE RETURNED USED 20130-01 SPIROS CONNECTOR INITIALLY RECORDED MIXED RESULTS. THE INITIAL TESTING OF THE USED 20130-01 SPIROS WHILE STILL ATTACHED TO THE 60ML SYRINGE WHERE THE SYRINGE WAS PRESSURIZED, RECORDED LEAKAGE ORIGINATING FROM THE SPIROS O-RING LOCATION. POST DECONTAMINATION TESTING WHERE THE SPIROS WAS ACTIVATED, AND AGAIN PRESSURIZED RECORDED NO LEAKAGE. MICROSCOPIC ANALYSIS OF THE USED SPIROS/COMPONENTRY RECORDED THE PRESENCE OF CLEAR PLASTIC PARTICULATE PARTIALLY WEDGED INTO THE O-RING AREA. THE SPIROS CONNECTOR WAS DISASSEMBLED, THE PARTICULATE REMOVED AND FOURIER TRANSFORM INFRARED SPECTROSCOPY WAS PERFORMED. THE RESULTS IDENTIFIED THE PARTICULATE TO BE PART OF THE SPIROS POLYCARBONATE BODY MATERIAL. TESTING AND ANALYSIS OF THE RETURNED PACKAGED 20130-01 SAME LOT SAMPLE WAS ALSO PERFORMED. THE RESULTS RECORDED THE DEVICE MET PRODUCT SPECS. THERE WERE NO LEAKAGES, NON-CONFORMANCES AND OR OUT OF SPEC CONDITIONS. RECORD REVIEWS: A REVIEW OF THE MFG LOT DATABASE FOR LOT #23-267-SL (MFG DATE 12/2012) SHOWS (B)(4) WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. A QUERY OF THE COMPLAINT DATABASE FOR THIS LIST/LOT # AND SIMILAR PROBLEM (PARTICULATE) RECORDED NO ADD'L REPORTS. CONCLUSION: TESTING AND ANALYSIS OF THE RETURNED PACKAGED 20130-01 SAME LOT SAMPLE RECORDED THE DEVICE MET PRODUCT AND PERFORMANCE SPECS. TESTING AND ANALYSIS OF THE USED 20130-01 DEVICE CONFIRMED THE LEAKAGE PROBLEM. THE CAUSE OF THE LEAKAGE WAS DUE TO THE PRESENCE OF PLASTIC PARTICULATE WHICH COMPROMISED THE O-RING SEAL. THE MFRS PRODUCT COMPLAINT TEAM, SUPPORT DISCIPLINES, AND INVOLVED ASSEMBLY/QUALITY PERSONNEL PERFORMED A REVIEW AND ANALYSIS OF THE OPERATIONAL SYSTEMS, EQUIPMENT, PROCESSING PARAMETERS AND PROCEDURES THAT ARE EXPECTED TO PREVENT THIS TYPE OF DEFECT FROM OCCURRING. THE REVIEW DETERMINED THAT THERE WAS NO SPECIFIC CAUSE OTHER THAN HUMAN ERROR/OVERSIGHT. CONTINUOUS IMPROVEMENT INITIATIVES AND HEIGHTENED INSPECTION OF AFFECTED PROCESSES HAVE BEEN INITIATED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING CHEMO LEAKAGE WITH USE OF ONE (1) 20130-01 SPINNING SPIROS CONNECTOR. IT WAS REPORTED "...UPON ADMINISTRATION THE DRUG (DOXORUBICIN) LEAKED OUT OF THE SYRINGE (NOT AT THE CONNECTION SITE ACCORDING TO THE NURSE)." THE CHEMO LEAKAGE WAS ATTENDED TO AND ATTENDING CLINICIAN WERE TREATED PER NORMAL HOSPITAL PROTOCOL. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO PT OR NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334242 SPINNING SPIROS CLOSED MALE LUER CONNECTER FPA ICU MEDICAL, INC. 20130-01 23-267-SL

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMO ACCESSORIES| 60 ML BD SYRINGE