BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    85" TEXIUM SET 20DP INLINE DP 1 YSITE

    MDR report key: 11312155 · Received February 11, 2021

    Report

    Report Number
    9616066-2021-50205
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 12, 2021
    Report Date
    May 7, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 19115547, 20055946, AND 20077111. A TREND REVIEW WAS PERFORMED FOR MODEL BG-70071-D-TP, NO ADDITIONAL COMPLAINT RELATED TO THIS FAILURE MODE WAS FOUND IN A 1-YEAR PERIOD (MAY 07, 2020 TO MAY 07, 2021) A TREND REVIEW WAS PERFORMED FOR MODEL BG-70071-D-TP, ONE QN (QN 200313904) RELATED TO THIS FAILURE MODE WAS FOUND IN A 1-YEAR PERIOD ((B)(6) 2020 TO (B)(6), 2021). PER PICTURE SHARED BY THE CUSTOMER IT WAS CONFIRMED THE WHITE MARKS ON THE OUTSIDE OF PIGTAIL, THEREFORE, A REVISION OF THE PROCESS THE WAS CONDUCTED WITH THE MFT. DURING THE REVISION, THE MFT CONFIRMED TO BE ACKNOWLEDGED ABOUT THIS ISSUE. A GEMBA WALK WAS PERFORMED AND PERSONNEL WERE INTERVIEWED. AFTER SHOWED THE PICTURE PROVIDED, PERSONNEL DID CONFIRM THAT THIS CONDITION HAS BEEN SEEN AND, THEREFORE, ALSO A QN FROM AUGUST 2020 WAS FOUND, WHERE THE ROOT CAUSE WAS THAT THE CURING TIME WASN¿T ENOUGH AND THAT WAS THE MAIN REASON OF THE MARKS IN THE TEXIUM DUE TO THE GASES EMITTED BY THE ADHESIVE (LOCTITE), THEREFORE, INSTEAD THE PERSONNEL LEAVE TO REST THE PIECES IN AN OPEN TRAY, DURING 3 HOURS, THAT PROCEDURE INDICATES. PER PREVIOUS INVESTIGATION REPORT THROUGH DIR # 10000382753, SOME PRODUCTION SAMPLES WERE ASSEMBLED AS INDICATES IN THE CURRENT MANUFACTURING PROCEDURE MFG0236, GENERAL ASSEMBLY INSTRUCTIONS DIR 10000202551. THE FAILURE MODE WAS REPLICATED WHEN THE MAXIMUM CURING TIME RECOMMENDED WAS PERFORMED (24 HOURS) USING THE CURRENTLY CURING METHOD, HOWEVER, ANOTHER EVALUATION WAS PERFORMED WITH A PROPOSED AIR CURING METHOD, TO CONFIRM THAT EVALUATION, A VENTILATED CAR AVAILABLE WAS USED UNDER CONTROLLED TEMPERATURE FOR TESTING PURPOSES, AFTER 3 HOURS IN THE CURING CAR, THE SAMPLES WERE PLACED IN A REST TRAY FOR 2 ADDITIONAL HOURS AND THE RESULT WAS 100% FREE OF CONTAMINATION. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 85" TEXIUM SET 20DP INLINE DP 1 YSITE FROM LOT 19115547, 1 SET FROM LOT 20055946, AND 1 SET FROM LOT 20077111 HAD WHITE "ETCHED" MARKINGS ON THEIR TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON JAN/15/2021 A USER REPORTED AN ISSUE WITH THE BG-70071-D-TP ADMINISTRATION SET WHERE THE, "SET HAD WHITE MARKINGS ON THE OUTSIDE OF THE PIGTAIL, IT ALMOST LOOKS AS IF THE PLASTIC HAS BEEN ETCHED. IT SEEMS AS IF IT IS ONLY ON THE OUTSIDE BUT I AM NOT SURE IF THIS TUBING IS SAFE TO USE." USER THEN CONFIRMED IT IS ON THE OUTSIDE OF THE NON-FLUID PATH OF THE TUBING. THIS WAS NOTICED THROUGH THREE LOTS (20077111, 20055946, 19115547)." "WAS NOTICED PRIOR CONNECTING TUBING TO A FLUID BAG. NO PATIENT INVOLVED. PATIENT WAS NOT HARMED."

    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 #: 19115547. MEDICAL DEVICE EXPIRATION DATE: 2022-11-11. DEVICE MANUFACTURE DATE: 2019-11-05. MEDICAL DEVICE LOT #: 20055946. MEDICAL DEVICE EXPIRATION DATE: 2023-05-09. DEVICE MANUFACTURE DATE: 2020-05-10. MEDICAL DEVICE LOT #: 20077111. MEDICAL DEVICE EXPIRATION DATE: 2023-07-23. DEVICE MANUFACTURE DATE: 2020-07-21. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 85" TEXIUM SET 20DP INLINE DP 1 YSITE FROM LOT 19115547, 1 SET FROM LOT 20055946, AND 1 SET FROM LOT 20077111 HAD WHITE "ETCHED" MARKINGS ON THEIR TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON JAN/15/2021 A USER REPORTED AN ISSUE WITH THE BG-70071-D-TP ADMINISTRATION SET WHERE THE, "SET HAD WHITE MARKINGS ON THE OUTSIDE OF THE PIGTAIL, IT ALMOST LOOKS AS IF THE PLASTIC HAS BEEN ETCHED. IT SEEMS AS IF IT IS ONLY ON THE OUTSIDE BUT I AM NOT SURE IF THIS TUBING IS SAFE TO USE." USER THEN CONFIRMED IT IS ON THE OUTSIDE OF THE NON-FLUID PATH OF THE TUBING. THIS WAS NOTICED THROUGH THREE LOTS (20077111, 20055946, 19115547)." "WAS NOTICED PRIOR CONNECTING TUBING TO A FLUID BAG. NO PATIENT INVOLVED. PATIENT WAS NOT HARMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213765 85" TEXIUM SET 20DP INLINE DP 1 YSITE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1