BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7-DAY LL VLV ADPT(STAND ALONE)

    MDR report key: 11478704 · Received March 14, 2021

    Report

    Report Number
    9616066-2021-50447
    Event Type
    Malfunction
    Date Received
    March 14, 2021
    Date of Event
    February 15, 2021
    Report Date
    May 27, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED: D10: DEVICE AVAILABLE FOR EVAL NO. D10: RETURNED TO MANUFACTURER ON: NA. H6: INVESTIGATION SUMMARY NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE PR 2439323 IN WHICH THE CUSTOMER HAS INDICATED THAT THE FEMALE LUER ADAPTOR (FLA) OF A 2000E7D SAMPLE FROM LOT 1012189 WAS FOUND TO BE OVAL. FURTHER REQUESTED INFORMATION PERTAINING TO THE ON-SITE STORAGE OF THE AFFECTED PRODUCT WAS NOT RECEIVED TO ASSIST THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1012189 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE; AND NO TEMPERATURE SPIKES WERE RECORDED DURING THE STERILIZATION PROCESS. THE ROOT CAUSE OF THE OVAL SHAPE IS EXPOSURE OF THE SMARTSITE COMPONENT TO AN EXTERNAL HEAT SOURCE THAT BRINGS THE COMPONENT TEMPERATURE ABOVE 60°C. THE BLUE PISTON HEAD OF THE SMARTSITE IS OVAL SHAPED BY DESIGN AND THEREFORE WHEN THE ROUND FLA COMPONENT IS PLACED OVER IT, THE PISTON OPENING IS SQUEEZED SHUT IN ORDER TO CREATE A SEAL. UNDER EXCESSIVE HEAT CONDITIONS, THE WHITE FLA MATERIAL CAN SOFTEN, AND AS THE PISTON PUSHES BACK ON THE INSIDE, IT CAN RESHAPE THE FLA TO CONFORM TO THE ORIGINAL OVAL SHAPE OF THE BLUE PISTON HEAD. PREVIOUS INVESTIGATIONS HAVE NOT FOUND A POTENTIAL ROOT CAUSE FOR THIS LEVEL OF EXCESS HEAT AS A RESULT OF ANY STAGE OF THE MANUFACTURING OR STERILIZATION PROCESSES AT THE MANUFACTURING SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7-DAY LL VLV ADPT(STAND ALONE) WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE BUNGS WAS OVAL AND ASSUMED TO BE STORED AT 60C AND WARPED AS A RESULT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 7-DAY LL VLV ADPT (STAND ALONE) WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE BUNGS WAS OVAL AND ASSUMED TO BE STORED AT 60C AND WARPED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375699 7-DAY LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1012189

    Patients

    Seq Age Sex Outcome Treatment
    1