BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT W/SS REM SPIN LUER & 1 SLD CLP

    MDR report key: 11860788 · Received May 20, 2021

    Report

    Report Number
    9616066-2021-51081
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 10, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403235016
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE WAS VERIFIED BY VISUAL INSPECTION. THE SAMPLE RECEIVED WAS SEEN TO HAVE A LARGE TEAR IN THE TUBING PARALLEL TO THE LONGITUDINAL AXIS OF THE TUBING. FURTHER TESTING ON THE SAMPLE COULD NOT BE CONDUCTED BECAUSE OF THE DAMAGE TO THE TUBING OF THE SAMPLE SUBMITTED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 22059E BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE INVESTIGATION WAS NOT ABLE TO FIND A DEFINITIVE ROOT CAUSE FOR THE PRODUCT FAILURE. THE PROBABLY ROOT CAUSE FOR THE ISSUE SEEN IN THIS COMPLAINT IS THAT THE TUBING BURST WHEN THE CUSTOMER ATTEMPTED TO FLUSH THE EXTENSION SET WHEN THEY NOTICED THAT BLOOD WAS BACKING UP INTO THE THE EXTENSION SET. THE BACKUP OF BLOOD INTO THE LINE AND THE INCREASE IN PRESSURE IN THE TUBING DUE TO THE CUSTOMER ATTEMPTING TO FLUSH THE LINE, CAUSED THE TUBING TO BURST. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXT W/SS REM SPIN LUER & 1 SLD CLP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 22059E BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THE DEVICE BLEW OUT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXT W/SS REM SPIN LUER & 1 SLD CLP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 22059E. BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THE DEVICE BLEW OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752009 EXT W/SS REM SPIN LUER & 1 SLD CLP INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 10885403235016

    Patients

    Seq Age Sex Outcome Treatment
    1