BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SE W/CV & 2 VLV PORTS 20 DRP

    MDR report key: 11509868 · Received March 17, 2021

    Report

    Report Number
    9616066-2021-50489
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 11, 2021
    Report Date
    June 3, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203010276
    PMA / PMN Number
    K931550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FOURTEEN 72023E SAMPLES WERE RECEIVED FOR INVESTIGATION; TEN OF THE SAMPLES WERE RECEIVED IN SEALED PACKAGING FROM LOT 18056238, ONE WAS RECEIVED WITH RESIDUAL FLUID THROUGHOUT THE LINE IN OPENED PACKAGING FROM LOT 18056238, AND THREE SAMPLES WERE RECEIVED WITHOUT PACKAGING WITH RESIDUAL FLUID IN THE LINE. ADDITIONALLY A PALL EXTENSION SET AND A PALL FILTER SET WERE RECEIVED CONNECTED TO TWO SAMPLES TO ASSIST THE INVESTIGATION. A VISUAL INSPECTION OF THE SAMPLES RECEIVED WITH RESIDUAL FLUID IDENTIFIED CRACKS AT VARIOUS LOCATIONS ON THE FRONT OF THE ACCUSLIDE COMPONENTS; LEAKAGE WAS CONFIRMED FROM THE DAMAGED COMPONENTS DURING FLUSHING. THE SAMPLES RECEIVED IN SEALED PACKAGING WERE THEN SUBJECTED TO PRESSURE TESTING IN ORDER TO OBSERVE IF ANY FURTHER SAMPLES HAD CRACKS IN THE ACCUSLIDE; LEAKAGE WAS OBSERVED FROM TWO OF THE SAMPLES DUE TO CRACKS AT THE ACCUSLIDE COMPONENT. NO DAMAGE OR LEAKAGE WAS IDENTIFIED FROM THE REMAINING EIGHT SAMPLE RECEIVED IN SEALED PACKAGING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE MANUFACTURING SITE CONFIRMED THAT THE ACCUSLIDE COMPONENT IS SUBJECTED TO A 100% LEAKAGE TESTING PROTOCOL PRIOR TO BEING ASSEMBLED INTO THE INFUSION SET; THEREFORE THE AFFECTED COMPONENTS WOULD HAVE BEEN IDENTIFIED PRIOR TO THE PACKAGING PROCESS. IN THIS INSTANCE THE DAMAGED COMPONENTS ARE LIKELY TO HAVE OCCURRED DUE TO BEING SUBJECTED TO AN EXTERNAL FORCE, THE ROOT CAUSE OF WHICH COULD NOT BE DETERMINED DURING THE INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 18056238 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SE W/CV & 2 VLV PORTS 20 DRP TUBING WAS DAMAGED, LEAKED, AND HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2021 VHIMS #(B)(4). ¿COMMENCED REPLACEMENT FLUID. NOTED AT 2 HOURS INTO ADMINISTRATION THAT THERE WAS A SMALL WET PATCH ON THE UNDER PUMP. EXAMINED THE LINE AS PREVIOUS DAY HAD ISSUES AND NOTED A CRACK TO THE MIDDLE OF THE GIVING SET WHICH WAS PLACED INTO THE PUMP. CRACK NOT PRESENT DURING ADMINISTRATION INTO THE PUMP, CHECKED BY MYSELF AS PREVIOUS DAY HAD ISSUES WITH GIVING SET IN SIMILAR MANNER.¿ IV MAINTENANCE NOTED ON VHIMS TO BE SODIUM CHLORIDE AND POTASSIUM CHLORIDE. LIPID HAS BACKFLOWED UP IV LINE FROM THE PATIENT END TO THE LOWER SMARTSITE (NOT SURE IF THE LIPID WAS CONNECTED AT THE LOWER SMART SITE, OR AT THE END OF THE IV LINE). O IV PACKAGE RETURNED WITH IV LINE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SE W/CV & 2 VLV PORTS 20 DRP TUBING WAS DAMAGED, LEAKED, AND HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2021, VHIMS # (B)(4). O ¿COMMENCED REPLACEMENT FLUID. NOTED AT 2 HOURS INTO ADMINISTRATION THAT THERE WAS A SMALL WET PATCH ON THE UNDER PUMP. EXAMINED THE LINE AS PREVIOUS DAY HAD ISSUES AND NOTED A CRACK TO THE MIDDLE OF THE GIVING SET WHICH WAS PLACED INTO THE PUMP. CRACK NOT PRESENT DURING ADMINISTRATION INTO THE PUMP, CHECKED BY MYSELF AS PREVIOUS DAY HAD ISSUES WITH GIVING SET IN SIMILAR MANNER.¿ O IV MAINTENANCE NOTED ON VHIMS TO BE SODIUM CHLORIDE AND POTASSIUM CHLORIDE. O LIPID HAS BACKFLOWED UP IV LINE FROM THE PATIENT END TO THE LOWER SMARTSITE (NOT SURE IF THE LIPID WAS CONNECTED AT THE LOWER SMART SITE, OR AT THE END OF THE IV LINE). O IV PACKAGE RETURNED WITH IV LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404787 SE W/CV & 2 VLV PORTS 20 DRP INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 18056238 07613203010276

    Patients

    Seq Age Sex Outcome Treatment
    1