BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP V/NV NTG 1.2MF 1SS DEHP FREE

    MDR report key: 11751009 · Received April 30, 2021

    Report

    Report Number
    9616066-2021-50866
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 20, 2021
    Report Date
    June 21, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE USED SAMPLE MODEL 10010453 WAS RETURNED FOR INVESTIGATION. THE RECEIVED SET CONTAINED LIPID SOLUTION WHICH WAS LEFT IN THE SET TO MORE CLOSELY REPLICATE THE REPORTED EVENT OF OCCLUSION. FOUR UNUSED SAMPLES MODEL 10010453 WERE RETURNED WITH THE USED SAMPLE FOR INVESTIGATION. PRIOR TO FUNCTIONAL TESTING THE SETS WERE VISUALLY EXAMINED FOR DEFECTS AND ABNORMALITIES. KINKS WERE FOUND IN THE USED TUBING SETS AND MASSAGED OUT. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED. THE UNUSED SETS WERE ATTACHED TO A BAG FILLED WITH BLUE DYE WATER AND ALLOWED TO PRIME. THE SAMPLES PRIMED AS EXPECTED. ALL SETS WERE THEN WERE THEN ATTACHED TO AN IV BAG FILLED WITH 85% GLYCERIN/ 15% WATER SOLUTION AND ALLOWED TO PRIME USING GRAVITY. THE SAMPLES SHOWED A MUCH SLOWER FLOW RATE THAN EXPECTED AND WERE UNABLE TO PRIME IN A REASONABLE TIME. DUE TO THE LIPID SOLUTION BEING IN THE FILTER AND LINE FOR AN EXTENDED PERIOD OF TIME THE SLOWER THAN EXPECTED FLOW IS POSSIBLY DUE TO THE VISCOSITY OF THE LIPID SOLUTION AND/OR THE POSSIBILITY OF THE LIPID SOLUTION COAGULATING. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10010453, LOT NUMBER 20105711 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FLOW ISSUES - FLUID BLOCKAGE WITH LOT #20105711 REGARDING ITEM #10010453.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP V/NV NTG 1.2MF 1SS DEHP FREE EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10010453, BATCH NO: 20105711. LIPID FILTER OCCLUDING WITH BOTH SMOF & INTRALIPIDS IN PEDS.

    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 20DP V/NV NTG 1.2MF 1SS DEHP FREE EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10010453, BATCH NO: 20105711. LIPID FILTER OCCLUDING WITH BOTH SMOF & INTRALIPIDS IN PEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652037 GEM 20DP V/NV NTG 1.2MF 1SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20105711

    Patients

    Seq Age Sex Outcome Treatment
    1