BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 1.2M

    MDR report key: 12112531 · Received July 2, 2021

    Report

    Report Number
    9616066-2021-51452
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 14, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403274037
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20075126. MEDICAL DEVICE EXPIRATION DATE: 2023-07-01. DEVICE MANUFACTURE DATE: 2020-06-29. MEDICAL DEVICE LOT #: 20026493. MEDICAL DEVICE EXPIRATION DATE: 2023-02-18. DEVICE MANUFACTURE DATE: 2020-02-18. MEDICAL DEVICE LOT #: 20105847. MEDICAL DEVICE EXPIRATION DATE: 2023-10-07. DEVICE MANUFACTURE DATE: 2020-10-06. MEDICAL DEVICE LOT #: 20075124. MEDICAL DEVICE EXPIRATION DATE: 2023-07-01. DEVICE MANUFACTURE DATE: 2020-06-29. MEDICAL DEVICE LOT #: 20086840. MEDICAL DEVICE EXPIRATION DATE: 2023-08-20. DEVICE MANUFACTURE DATE: 2020-08-15. MEDICAL DEVICE LOT #: 20086841. MEDICAL DEVICE EXPIRATION DATE: 2023-08-20. DEVICE MANUFACTURE DATE: 2020-08-15. MEDICAL DEVICE LOT #: 20096797. MEDICAL DEVICE EXPIRATION DATE: 2023-09-21. DEVICE MANUFACTURE DATE: 2020-09-19. MEDICAL DEVICE LOT #: 19095571. MEDICAL DEVICE EXPIRATION DATE: 2022-09-09. DEVICE MANUFACTURE DATE: 2019-09-06 MEDICAL DEVICE LOT #: 20105914. MEDICAL DEVICE EXPIRATION DATE: 2023-10-08. DEVICE MANUFACTURE DATE: 2020-10-06. MEDICAL DEVICE LOT #: 19106241. MEDICAL DEVICE EXPIRATION DATE: 2022-10-22. DEVICE MANUFACTURE DATE: 2019-10-15. MEDICAL DEVICE LOT #: 19046304. MEDICAL DEVICE EXPIRATION DATE: 2022-04-17. DEVICE MANUFACTURE DATE: 2019-04-13. MEDICAL DEVICE LOT #: 19095563. MEDICAL DEVICE EXPIRATION DATE: 2022-09-06. DEVICE MANUFACTURE DATE: 2019-09-06. MEDICAL DEVICE LOT #: 20075125. MEDICAL DEVICE EXPIRATION DATE: 2023-07-01. DEVICE MANUFACTURE DATE: 2020-06-29. MEDICAL DEVICE LOT #: 20115719. MEDICAL DEVICE EXPIRATION DATE: 2023-11-04. DEVICE MANUFACTURE DATE: 2020-11-04. MEDICAL DEVICE LOT #: 20115722. MEDICAL DEVICE EXPIRATION DATE: 2023-11-05. DEVICE MANUFACTURE DATE: 2020-11-04. MEDICAL DEVICE LOT #: 20105848. MEDICAL DEVICE EXPIRATION DATE: 2023-10-07. DEVICE MANUFACTURE DATE: 2020-10-06. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED WIDESPREAD LEAKAGE IN THEIR MODEL # 2202-0007 TUBING SETS, AND RETURNED 208 UNUSED SAMPLES IN ORIGINAL PACKAGING. DESPITE THE LOT NUMBER BEING UNKNOWN, THERE WERE 16 DIFFERENT LOT #S INCLUDED, ALL OF WHICH HAD CHC AND DHR RUN. ALL LOT #S DESPITE 20115719 WERE 100% TESTED FOR LOOSE CONNECTIONS IN THE TUBING. PRIMING OF THE TUBING FOUND NO ISSUES. SAMPLE SIZE WAS APPLIED FOR LOT #20115719 AND 59 SAMPLES WERE TESTED. THERE WAS ONE FAILURE IN LOT #20115719 WHERE THE FILTER OUTLET HAD BROKEN OFF WHILE IN THE BAG. THE ROOT CAUSE FOR THIS IS UNKNOWN. SAMPLES WERE TESTED BY PRIMING WITH BLUE DYE FLUID AND MANIPULATING THE CONNECTIONS IN ORDER TO FIND ANY WEAK OR LOOSE CONNECTIONS. THE CUSTOMER COMPLAINT OF LEAKAGE WAS VERIFIED BY THE FILTER IN LOT #20115719.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AS LVP 20D 1.2M TUBING LEAKED. THIS EVENT OCCURRED AT LEAST 7 TIMES IN LOT 20075126, 4 TIMES IN LOT 20026493, 7 TIMES IN LOT 20105847, TWICE IN LOT 20075124, 5 TIMES IN LOT 20086840, ONCE IN LOT 20086841, 9 TIMES IN LOT 20096797, 3 TIMES IN LOT 19095571, 4 TIMES IN LOT 20105914, 5 TIMES IN LOT 19106241, 4 TIMES IN LOT 19046304, 6 TIMES IN LOT 19095563, 4 TIMES IN LOT 20075125, 79 TIMES IN LOT 20115719, 45 TIMES IN LOT 20115722, AND 23 TIMES IN LOT 20105848. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DUE TO MANY FAILURES OF TUBING LEAKING WE REMOVED ALL PRODUCT OFF OUR SHELVES"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006466 AS LVP 20D 1.2M INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2202-0007 SEE SECTION H.10. 50885403274037

    Patients

    Seq Age Sex Outcome Treatment
    1