BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP CKV 3SS DEHP FREE

    MDR report key: 11646321 · Received April 9, 2021

    Report

    Report Number
    9616066-2021-50690
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 17, 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
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 3/15/2021 INVESTIGATION: ONE SAMPLE WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THE DCHU RECEIVED AN ADDITIONAL SAMPLE THAT WAS NOT REPORTED BY THE CUSTOMER. THIS SAMPLE WAS RETURNED DUE TO A FLUID BLOCKAGE-OCCLUSION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS SUCCESSFULLY PRIMED. THE SET WAS INFUSED WITH THE BD ALARIS PUMP MODULE (DCHU-0008) AT 125 ML/HR WITH A VTBI OF 125 ML. NO ISSUES WERE OBSERVED THROUGHOUT THE INFUSION. THE INFUSION WAS COMPLETED SUCCESSFULLY. ALL SMARTSITE PORTS WERE ABLE TO BE INJECTED WITH WATER. THE FAILURE WAS UNABLE TO BE REPLICATED, AND THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2426-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. A ROOT CAUSE WAS UNABLE TO BE DETERMINED BECAUSE THE FAILURE WAS UNABLE TO BE REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED FLOW ISSUES AND WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2426-0007 BATCH/ LOT #: UNKNOWN RECEIVED ADDITIONAL SAMPLES THAT WERE NOT REPORTED BY THE CUSTOMER. THIS SAMPLE WAS RETURNED DUE TO FLUID BLOCKAGE- OCCLUSION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. 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 FLOW ISSUES AND WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2426-0007 BATCH/ LOT #: UNKNOWN. RECEIVED ADDITIONAL SAMPLES THAT WERE NOT REPORTED BY THE CUSTOMER. THIS SAMPLE WAS RETURNED DUE TO FLUID BLOCKAGE- OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541722 GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1