BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP CKV 3SS DEHP FREE

    MDR report key: 10554310 · Received September 18, 2020

    Report

    Report Number
    9616066-2020-02781
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 26, 2020
    Report Date
    August 26, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203020985
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED A KINK IN THE TUBING AND MEDS WERE NOT INFUSING. RECEIVED FROM THE CUSTOMER IS ONE USED PRIMARY SET MODEL 2426-0007 LOT UNKNOWN. THE SET WAS RECEIVED WITH TRACES OF FLUID THROUGHOUT THE TUBING. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO KINKS OR OTHER ANOMALIES WERE OBSERVED WITH THE RECEIVED SET DURING VISUAL INSPECTION. FUNCTIONAL TESTING WAS PERFORMED BY FILLING A LAB IV BAG WITH BLUE DYE WATER AND ATTACHING IT TO THE SET ALLOWING FLUID TO FLOW THROUGH THE WHOLE SET VIA GRAVITY. FLUID FLOWED FREELY AND SHOWED NO SIGNS OF OCCLUDING. THE SET WAS LOADED INTO A LAB PUMP MODULE FOR AN INFUSION TEST. THE PRIMARY INFUSION WAS PROGRAMMED AT A RATE OF 125ML/H AND 125 ML VTBI. THE INFUSION COMPLETED SUCCESSFULLY WITH NO OCCLUSIONS OR OCCLUSION ALARMS THROUGHOUT THE SET. EQUIPMENT USED FOR TESTING PERFORMED ON 21SEP2020: 8015 ALARIS PCU 1.5 #1, EQ08330, 4-AUG-21 8100 ALARIS SYSTEM LVP, #3 EQ08470, 5-JUN-21 DEVICE HISTORY RECORD FOR MODEL 2426-0007 COULD NOT BE PERFORMED DUE TO NO LOT NUMBER BEING PROVIDED BY CUSTOMER. THE CUSTOMER¿S REPORT OF A KINK IN THE TUBING AND MEDS WERE NOT INFUSING WAS NOT CONFIRMED. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT COULD NOT BE IDENTIFIED BECAUSE NO KINKS WERE OBSERVED THROUGHOUT THE SET AND THE SET FUNCTIONED PROPERLY WITH NO OCCLUSIONS OCCURRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: KINKED TUBING. CONNECTED TO IV PUMP; MEDS WERE NOT INFUSING. TUBING WAS REMOVED/REPLACED AND ISSUE WAS RESOLVED WITH NO HARM TO THE PATIENT. PACKAGING WAS DISCARDED AND COULD NOT BE RECOVERED, BUT TUBING WAS SAVED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: KINKED TUBING. CONNECTED TO IV PUMP; MEDS WERE NOT INFUSING. TUBING WAS REMOVED/REPLACED AND ISSUE WAS RESOLVED WITH NO HARM TO THE PATIENT. PACKAGING WAS DISCARDED AND COULD NOT BE RECOVERED, BUT TUBING WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020323 GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN 07613203020985

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 8100,8015, 20200826| 8100,8015, 20200826| 8100,8015, 20200826