BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO EXT SET W/1 SS VLV

    MDR report key: 10694548 · Received October 17, 2020

    Report

    Report Number
    9616066-2020-20086
    Event Type
    Malfunction
    Date Received
    October 17, 2020
    Date of Event
    July 24, 2020
    Report Date
    October 23, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403233577
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10010983 LOT NUMBER 20055744 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MICRO EXT SET W/1 SS VLV TUBING WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 1001983 LOT NO.: 20055744. IT WAS REPORTED THAT THERE WAS AN OCCLUSION WITHIN THE TUBING SETS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MICRO EXT SET W/1 SS VLV TUBING WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 1001983, LOT NO.: 20055744. IT WAS REPORTED THAT THERE WAS AN OCCLUSION WITHIN THE TUBING SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159376 MICRO EXT SET W/1 SS VLV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10010983 20055744 50885403233577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other