BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D DEHP 3SS CV

    MDR report key: 11732081 · Received April 27, 2021

    Report

    Report Number
    2243072-2021-01267
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    February 19, 2021
    Report Date
    June 21, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AS LVP 20D DEHP 3SS CV HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT AN IV SET WAS OCCLUDED IN THE LVP AND THE ALARM NEVER WAS ACTIVATED. D.1. MEDICAL DEVICE BRAND NAME: AS LVP 20D DEHP 3SS CV. D.3. MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. (TIJUANA). D.4 MEDICAL DEVICE CATALOG#: 2426-0500. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. (TIJUANA). G.4. PMA / 510(K)#: K944320. H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT AN IV SET WAS OCCLUDED IN THE LVP AND THE ALARM NEVER WAS ACTIVATED COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS LVP 20D DEHP 3SS CV HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT AN IV SET WAS OCCLUDED IN THE LVP AND THE ALARM NEVER WAS ACTIVATED.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). 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 UNSPECIFIED BD¿ IV SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT AN IV SET WAS OCCLUDED IN THE LVP AND THE ALARM NEVER WAS ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630758 AS LVP 20D DEHP 3SS CV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1