BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 11033591 · Received December 17, 2020

    Report

    Report Number
    9616066-2020-20610
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 17, 2020
    Report Date
    January 12, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 2020-12-09. H6: INVESTIGATION SUMMARY: NINE 2000E-04 SAMPLES FROM LOT 20055504 WERE RECEIVED FOR INVESTIGATION OF PR 2091088; EIGHT IN SEALED PACKAGING AND ONE IN OPENED PACKAGING. A VISUAL INSPECTION OF THE SAMPLE RECEIVED IN OPENED PACKAGING DID NOT IDENTIFY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. FUNCTIONAL TESTING WAS PERFORMED BY CONNECTING A 50ML BD PLASTIPAK SYRINGE FROM BD STOCK TO THE SAMPLE AND FLUSHING WITH FLUID; NO OCCLUSION OR FLOW RESTRICTION WAS IDENTIFIED DURING TESTING. THE EIGHT SAMPLES RECEIVED IN SEALED PACKAGING WERE THEN SUBJECTED TO FUNCTIONAL TESTING USING A 50ML BD PLASTIPAK SYRINGE, AGAIN NO OCCLUSIONS OR FLOW RESTRICTIONS WERE OBSERVED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE IN THIS INSTANCE AS TESTING OF THE RETURNED SAMPLES DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20055504 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT REPORTS OF THIS NATURE AGAINST THE STANDALONE SMARTSITE DEVICE OCCUR AT A LOW FREQUENCY AND HAVE NOT BEEN ATTRIBUTABLE TO A PRODUCT DEFECT OR MANUFACTURING ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 LL VLV ADPT(STAND ALONE) EXPERIENCED DEFORMATION/DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING PATIENT PROCEDURES THE "ELBOW" IS CRACKING/ SNAPPING/ BREAKING CAUSING AIRWAYS TO BE COMPROMISED. THEY FAIL TO ALLOW FLOW OF FLUID WHEN SYRINGE ATTACHED. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 2005504 WAS PROVIDED BY THE INITIAL REPORTER. 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 5 LL VLV ADPT (STAND ALONE) EXPERIENCED DEFORMATION/DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING PATIENT PROCEDURES THE "ELBOW" IS CRACKING/ SNAPPING/ BREAKING CAUSING AIRWAYS TO BE COMPROMISED. THEY FAIL TO ALLOW FLOW OF FLUID WHEN SYRINGE ATTACHED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497377 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1