BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7-DAY LL VLV ADPT(STAND ALONE)

    MDR report key: 11313755 · Received February 11, 2021

    Report

    Report Number
    9616066-2021-50210
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 18, 2021
    Report Date
    February 26, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 2/2/2021. H6: INVESTIGATION: THREE 2000E7D SAMPLES WERE RECEIVED FOR INVESTIGATION. TWO OF THE SAMPLES WERE RECEIVED WITHOUT PACKAGING, WHILST THE THIRD WAS RECEIVED IN SEALED PACKAGING FROM LOT 1012189. NO SAMPLE OF THE CONNECTING PRODUCT WAS RECEIVED TO ASSIST THE INVESTIGATION. DURING SUBSEQUENT CORRESPONDENCE WITH THE CUSTOMER, IT WAS CLARIFIED THAT THE INJECTOR ABORTS THE ADMINISTRATION OF CONTRAST AND/OR SALINE, DUE TO THE OBSERVED PRESSURE BREACHING THE REQUIRED LIMITS. THE CUSTOMER ALSO INDICATED THAT THE ISSUES HAVE APPEARED ANYWHERE BETWEEN 2.5ML/SEC AND 5.5ML/SEC AND PRESSURES BETWEEN 250PSI AND 325PSI. THE THREE RECEIVED SAMPLES WERE ALL SUCCESSFULLY ACCESSED WITH BD PLASTIPAK SYRINGES; IN EACH INSTANCE THE CONNECTION WAS SECURE AND NO FLOW RESTRICTIONS OR BLOCKAGES WERE ENCOUNTERED. 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. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED; HOWEVER PREVIOUS REPORTS OF A SIMILAR NATURE HAVE BEEN FOUND TO BE RELATED TO FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCT. THESE FEATURES, INCLUDING FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER, HAVE PREVIOUSLY BEEN SHOWN TO LEAD TO INTERMITTENT RESTRICTED FLOW DUE TO THEM PINCHING THE BLUE PISTON OF THE SMARTSITE AND NOT ALLOWING IT TO OPEN. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7-DAY LL VLV ADPT(STAND ALONE) HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SUBSEQUENT ISSUES HAVE OCCURRED DURING USE OF THE MEDRAD CT INJECTORS WHERE THE INJECTION STOPS WELL BEFORE THE FULL INJECTION OF CONTRAST AT VARIOUS FLOW RATES, PRESSURE, AND CONTRASTS. MULTIPLE USERS HAVE EXPERIENCED THIS ISSUE. CE IS CURRENTLY INVESTIGATING THE INJECTORS. SUPPLY CHAIN IS LOOKING AT THE IV BUNGS WE HAVE COLLECTED. ALSO THE DISPOSABLE INJECTOR KIT COMPONENTS WILL NEED TO BE EVALUATED TO RULE OUT ALL COMPONENTS INVOLVED IN THE PROCESS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 1012189. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 7-DAY LL VLV ADPT(STAND ALONE) HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SUBSEQUENT ISSUES HAVE OCCURRED DURING USE OF THE MEDRAD CT INJECTORS WHERE THE INJECTION STOPS WELL BEFORE THE FULL INJECTION OF CONTRAST AT VARIOUS FLOW RATES, PRESSURE, AND CONTRASTS. MULTIPLE USERS HAVE EXPERIENCED THIS ISSUE. CE IS CURRENTLY INVESTIGATING THE INJECTORS. SUPPLY CHAIN IS LOOKING AT THE IV BUNGS WE HAVE COLLECTED. ALSO THE DISPOSABLE INJECTOR KIT COMPONENTS WILL NEED TO BE EVALUATED TO RULE OUT ALL COMPONENTS INVOLVED IN THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213531 7-DAY 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