BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11309037 · Received February 10, 2021

    Report

    Report Number
    9617594-2021-00038
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 20, 2021
    Report Date
    January 21, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026615
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTOGRAPH WAS PROVIDED AND EVALUATED. THE PHOTO SHOWS THE CHEMOCLAVE OF AN EXTENSION SET CONNECTED TO A SPIROS AND THE SPIROS IS CONNECTED TO A SYRINGE. NO VISIBLE DAMAGE, ANOMALIES OR LEAKAGE CAN BE SEEN. ONE USED LIST# CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP (LOT# 5000437), ONE USED 50 ML BD SYRINGE, AND ONE USED EXTENSION SET W/ CLAVE AND SPIROS, (LIST # UNKNOWN, LOT# UNKNOWN) WERE RECEIVED AND VISUALLY INSPECTED. AS RECEIVED, THE SPIROS WAS SECURELY CONNECTED TO THE BD SYRINGE. RED DRUG RESIDUALS WERE PRESENT WITHIN THE SPIROS HOUSING. NO DAMAGE OR ANOMALIES WERE SEEN ON THE RETURNED EXTENSION SET AND SYRINGE. THE SPINNING SPIROS WAS LEAK TESTED WHILE APPLYING LIGHT BENDING/ROTATING FORCES THAT WOULD BE TYPICAL OF USE. A SLOW LEAK WAS OBSERVED FROM THE AREA OF THE SPIROS O-RING/POPPET INTERFACE. THE SPIROS WAS DISASSEMBLED AND NO DAMAGE OR ANOMALIES THAT WOULD RESULT IN A LEAK WERE OBSERVED. DIMENSIONAL ANALYSIS OF THE POPPET, THE OD OF THE O-RING, AND THE O-RING POST WAS PERFORMED. ALL COMPONENTS WERE FOUND TO MEET DESIGN SPECIFICATIONS. THE REPORTED LEAK FROM THE SPIROS CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE LEAK IS UNKNOWN. D9: DATE RETURNED TO MFG - FEBRUARY 10, 2021.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT THE CUSTOMER REPORTED A LEAK OF DOXORUBICIN DURING USE ON A PATIENT IN THE PEDIATRIC ONCOLOGY CLINIC. THE TUBING SET WAS ATTACHED TO THE SYRINGE VIA A SPIROS CONNECTOR. THE LENGTH OF THE SYRINGE PLUS THE LENGTH OF THE SPIROS AND THE TUBING, EXTENDED BEYOND THE TUBING GUIDES ON THE PUMP, CAUSING AN UPWARD BEND AT THE SPIROS-SYRINGE JUNCTION, WHERE A LEAK WAS NOTED AND DOXORUBICIN WAS FOUND TO BE POOLING ON TOP OF THE SYRINGE INFUSION PUMP. THE CUSTOMER ALSO NOTED THAT FOR ANY SYRINGES > 30ML, WHEN THEY ADD THE SPIROS AND THE TUBING SET, THE LENGTH CAUSES SOME BENDING ISSUES WITH THE SYRINGE INFUSION PUMP. THERE WAS NO BLOOD LOSS OR BLEEDBACK REPORTED. THE DRUG WAS REPLACED. THE CHEMO SPILL WAS CLEANED UP PER PROTOCOL. THERE WAS PATIENT INVOLVEMENT, AND ALTHOUGH THE PATIENT RECEIVED A LOWER THEN ORDERED DOSE DUE TO THE LEAK, THERE WAS NO DIRECT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203840 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5000437 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 >30ML UNSPECIFIED SYRINGE, MFR UNK| DOXORUBICIN, MFR UNK| UNSPEC SYRINGE PUMP, MFR UNK| UNSPEC TUBING SET, MFR UNK| >30ML UNSPECIFIED SYRINGE, MFR UNK| DOXORUBICIN, MFR UNK| UNSPEC SYRINGE PUMP, MFR UNK| UNSPEC TUBING SET, MFR UNK