BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS, SPINNING CONNECTOR

    MDR report key: 4742993 · Received April 28, 2015

    Report

    Report Number
    2025816-2015-00026
    Event Type
    Malfunction
    Date Received
    April 28, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 28, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: 02/06 TWO USED 20130-01 CONNECTORS; 20 ML BD SYRINGE; UNIDENTIFIED EXT. TUBING SET AND ON 02/27 A SECOND RETURN OF 100 PACKAGED 20130-01 CONNECTORS RECORDED EXTENSIVE CRACKS IN THE FEMALE LUER ON ONE OF THE 20130-01 CONNECTORS. THIS CONDITION WOULD RESULT IN THE REPORTED LEAKAGE. THERE WERE NO VISUAL ABNORMALITIES SEEN ON THE SECOND 20130-01 OR RETURNED SYRINGE AND EXT SET MATING DEVICES. ENGINEERING EVALUATIONS: THE UNDAMAGED USED 20130-01 AND SAMPLE QTYS OF THE PKGD UNITS WERE PRESSURE LEAK TESTED PER THE APPLICABLE PROD SPEC. THE RESULTS RECORDED NO LEAKAGES OR OUT OF SPEC CONDITIONS. ADD'L TESTING WAS PERFORMED WITH SAMPLE QUANTITIES OF THE RETURNED PKGD 20130-01 CONNECTORS. FIVE SAMPLE UNITS WERE EXPOSED TO CYCLOSPORINE PRIOR TO CONNECTION TO 20 ML LUER LOCK SYRINGES AND FIVE SAMPLE UNITS WERE CONNECTED "DRY" TO 20 ML LUER LOCK SYRINGES. THE SET-UPS WERE STORED AT ROOM TEMP FOR THREE DAYS AND THEN EVALUATED. THE RESULTS RECORDED THE SAMPLE UNITS THAT HAS BEEN EXPOSED TO CYCLOSPORINE EXHIBITED CRACKS ON THE FEMALE LUERS. NONE OF THE SAMPLES THAT WERE CONNECTED DRY HAD ANY EVIDENCE OF CRACKING. THE ENGINEERS REPORT DETERMINED THIS TYPE OF CRACKING. THE ENGINEERS REPORT DETERMINED THIS TYPE OF CRACKING IS CHARACTERISTIC OF ENVIRONMENTAL STRESS CRACKING. FINDINGS: COMPONENT DAMAGE/CRACKING AND SUBSEQUENT LEAKAGE OF THE 20130-01 CONNECTORS FEMALE LUER WAS CONFIRMED ON ONE OF THE TWO USED "AS-REC'D" 20130-01 CONNECTORS. ADD'L TESTING OF PREPARED/STORED SET-UPS WHERE "WET" MATING ATTACHMENTS WERE USED ALSO REPLICATED SIMILAR COMPONENT DAMAGES. THE ENGINEERING REPORT DETERMINED THAT UNDER THESE TYPES OF USAGE CONDITIONS IT IS POSSIBLE FOR ENVIRONMENTAL STRESS CRACKING TO OCCUR WHEN PLASTIC IS EXPOSED TO CHEMICAL SUBSTANCES THAT WEAKENS THE PLASTIC WHILE THE PLASTIC IS UNDER STRESS. THE FINDINGS AND RECOMMENDATION TO UTILIZE "DRY" CONNECTION WHEN PREPARING THESE TYPES OF SET-UPS HAVE BEEN DISCUSSED WITH THE FACILITIES CLINICAL STAFF.

    Description of Event or Problem · 1

    (B)(4) REPORT REC'D RECEIVED CONCERNING LEAKAGE ISSUES WERE 20130-01 SPINNING SPIROS CONNECTORS WERE IN USE. THE (B)(4) REPORT DESCRIBES THE EVENTS AS FOLLOWS: "NURSES HAVE ENCOUNTERED THEIR PTS CYCLOSPORINE DOES HAS BEEN LEAKING... NOTED CRACKS IN THE SPINNING SPIROS CONNECTION PIECE THAT IS ATTACHED TO THE SYRINGE. THE PHARMACY HAS BEEN DRAWING UP THESE CHEMOTHERAPY DOSES". ALTHOUGH REQUESTED ADD'L. DEVICE SET-UP; STORAGE CONDITIONS; USAGE AND DRUG FORMULATION HAS NOT BEEN PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277290 SPIROS, SPINNING CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 20130-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PUMP DELIVERY TUBING SETS| SYRINGE