BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PXVFP11274

    MDR report key: 17987151 · Received October 23, 2023

    Report

    Report Number
    2015691-2023-16993
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Report Date
    December 18, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXO
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO PRODUCT EVALUATION FINDINGS. SECTIONS G6, H2, H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED. THE (B)(4), PRESSURE MONITORING SET WAS RETURNED FOR EVALUATION. ONE WHITE PARTICULATE WAS OBSERVED INSIDE THE VAMP FLEX RESERVOIR (FLOATED IN SOLUTION) DURING VISUAL EXAMINATION. THE PARTICULATE WAS APPROXIMATELY 2 MM X 1 MM IN SIZE. THE PLUNGER OF THE VAMP FLEX WAS PUSHED TO A CLOSED POSITION AT RATE OF 1ML PER 1 SECOND, BUT THE PARTICULATE STAYED INSIDE VAMP FLEX RESERVOIR. IT WAS RECOMMENDED BY IFU TO MOVE THE PLUNGER AT RATE OF 1ML PER 1 SECOND. THE WHOLE LINE WAS FLUSHED CONTINUOUSLY FOR 5 MINUTES, BUT THE PARTICULATE STAYED INSIDE VAMP FLEX AFTER 5 MINUTES OF CONTINUOUS FLUSHING. NO OTHER VISIBLE INCONSISTENCY WAS OBSERVED ON THE RETURNED KIT. THE PARTICULATE WAS REMOVED FROM THE RESERVOIR, AND THE PARTICULATE APPEARED TO BE A GEL-LIKE MATERIAL. PER CHEMISTRY STUDY THE IR SPECTRUM OF THE WHITE GEL LIKE MATERIAL WAS CONSISTENT WITH THAT OF POLY (OCTADECYL ACRYLATE). DURING THE EXECUTION OF THE ENGINEERING EVALUATION PROCESS, IT WAS IDENTIFIED THAT THE INVOLVED COMPONENT IS MANUFACTURED BY THE "PROCEDURE PRODUCTS INC." SUPPLIER; SINCE THIS UNKNOWN MATERIAL SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO POLY (OCTADECYL ACRYLATE) LIKE MATERIAL DOES NOT INTERACTION DURING MANUFACTURING PROCESS, THEREFORE, THIS DEFECT IS CONSIDERED AS A SUPPLIER RELATED CONDITION AND THE CORRESPONDING SUPPLIER NOTIFICATION WAS SENT DUE TO MAIL BY THE DR SUPPLIER QUALITY TEAM.

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION. WHEN THE PRODUCT EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY REVIEW WAS COMPLETED AND ALL INSPECTIONS PASSED WITH NO NONCONFORMANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN MATERIAL WAS FOUND INSIDE THE VAMP FLEX SYRINGE BEFORE USE. FURTHER DETAILS SUCH AS WHAT KIND OF MATERIAL IT WAS WHETHER THE PACKAGE IS OPENED OR NOT AND PATIENT INFORMATION COULD NOT BE OBTAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855822 PXVFP11274 PRESSURE MONITORING SET DXO EDWARDS LIFESCIENCES PXVFP11274 YH0648MT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown