BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP V/NV CKV 3SS

    MDR report key: 10703499 · Received October 20, 2020

    Report

    Report Number
    9616066-2020-20109
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 28, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203021167
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE OF MODEL 10012144 INFUSION SET WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF KINKED TUBING WAS VERIFIED BY VISUAL INSPECTION. NO FURTHER DEFECTS OR DAMAGES WERE OBSERVED UPON VISUAL INSPECTION OF THE TUBING. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 1001214 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. PREVIOUS INVESTIGATIONS HAVE INDICATED THE ROOT CAUSE FOR THIS ISSUE IS AN INCORRECT ASSEMBLY METHOD OF THE SET BEING COILED AND POUCHED PRIOR TO SOLVENT FULLY DRYING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP V/NV CKV 3SS EXPERIENCED KINKED TUBING AND WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10012144 BATCH NO: (AN INVALID LOT # WAS PROVIDED AS 20016683) WE HAD AN ALARIS TUBING INCIDENT YESTERDAY. THE TUBING WAS KINKED BELOW THE DRIP CHAMBER SO FLUID WOULD NOT FLOW INTO THE TUBING, NO MATTER WHAT THEY TRIED.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM 20DP V/NV CKV 3SS EXPERIENCED KINKED TUBING AND WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10012144 BATCH NO: (AN INVALID LOT # WAS PROVIDED AS 20016683) WE HAD AN ALARIS TUBING INCIDENT YESTERDAY. THE TUBING WAS KINKED BELOW THE DRIP CHAMBER SO FLUID WOULD NOT FLOW INTO THE TUBING, NO MATTER WHAT THEY TRIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169330 GEM 20DP V/NV CKV 3SS INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10012144 UNKONWN 37613203021167

    Patients

    Seq Age Sex Outcome Treatment
    1