BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV 20D 1CV 2SS DEHP FREE

    MDR report key: 10299873 · Received July 20, 2020

    Report

    Report Number
    9616066-2020-02274
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 10, 2020
    Report Date
    June 29, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PRIOR TO RUNNING IV MEDICATIONS FOR AN OUTPATIENT INFUSION, THE IV TUBING WAS PRIMED AND FOUND TO HAD EITHER A HOLE OR SPLIT IN TUBING EVIDENCED BY LEAKING ONTO FLOOR. THE IV TUBING WAS NEVER ATTACHED TO THE PATIENT SO NO HARM WAS EXPERIENCED. RECEIVED FROM THE CUSTOMER WAS ONE USED PRIMED SET MODEL 2420-0007 LOT 20023020 (WITH ITS PACKAGING POUCH). THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION OBSERVED A CUT/SLICE ON THE VINYL TUBING (P/N 660132) AT 25 INCHES BELOW THE DISTAL TUBING ADAPTER (P/N 601529). NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED THROUGHOUT THE SET. FLUID WAS OBSERVED TO BE LEAKING FROM THE CUT TUBING. PACKAGING POUCH RECEIVED WAS ALSO VISUALLY INSPECTED, AND IT WAS ALSO NOTED TO HAVE SLICE CUT. FUNCTIONAL TESTING WAS PERFORMED BY SPIKING THE PRIMARY SET TO ONE LAB IV BAG FILLED WITH BLUE DYE WATER AND BY ALLOWING FLUID TO FLOW THROUGH THE WHOLE SET BY GRAVITY. THE SET LEAKED FROM THE TUBING CUT THAT WAS OBSERVED DURING VISUAL INSPECTION. NO OTHER LEAKS WERE OBSERVED THROUGHOUT THE SET. EQUIPMENT USED (INSPECTION PERFORMED ON (B)(6) 2020): - RAM OPTICAL INSTRUMENTATION/EQ08204/CALIBRATION DUE DATE 5-FEB-2021 DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 20023020 SHOWS THAT THE SET WAS MANUFACTURED ON 7 FEBRUARY 2020 WITH A TOTAL OF (B)(4) UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. THE CUSTOMER¿S REPORT THAT THE TUBING SET LEAKED DUE TO A HOLE OR SPLIT IN THE TUBING WAS CONFIRMED DUE TO A SLICE/CUT IN THE TUBING. THE CAUSE OF THE LEAK IN THE TUBING WAS IDENTIFIED AS DAMAGE FROM A SLICE CUT IN THE PACKAGING POUCH. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE AND RUPTURED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO RUNNING IV MEDICATIONS FOR AN OUTPATIENT INFUSION, THE IV TUBING WAS PRIMED AND FOUND TO HAD EITHER A HOLE OR SPLIT IN TUBING EVIDENCED BY LEAKING ONTO FLOOR. THE IV TUBING WAS NEVER ATTACHED TO THE PATIENT SO NO HARM WAS EXPERIENCED. THE EVENT HAPPENED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE AND RUPTURED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO RUNNING IV MEDICATIONS FOR AN OUTPATIENT INFUSION, THE IV TUBING WAS PRIMED AND FOUND TO HAD EITHER A HOLE OR SPLIT IN TUBING EVIDENCED BY LEAKING ONTO FLOOR. THE IV TUBING WAS NEVER ATTACHED TO THE PATIENT SO NO HARM WAS EXPERIENCED. THE EVENT HAPPENED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763825 GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20023020 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200610| 20200610| 20200610