BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PRI TUBING

    MDR report key: 10485283 · Received September 2, 2020

    Report

    Report Number
    9616066-2020-02689
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 11, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF THE TUBING MISSING THE SAFETY CLAMP AND THEREFORE COULD NOT BE USED OR LOADED INTO PUMP COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL UNKNOWN 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. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED. ROOT CAUSE DESCRIPTION: 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 · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD PRI TUBING EXPERIENCED A MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TYPE OF DEVICE: SET, ADMINISTRATION, INTRAVASCULAR, DEVICE BRAND NAME: ALARIS, SMARTSITE, DEVICE MANUFACTURER'S NAME: CAREFUSION 303, INC., DATE OF THIS REPORT: 07/06/2020. DESCRIBE THE EVENT OR PROBLEM: INFUSION PUMP SET WAS MISSING SAFETY CLAMP AND COULD NOT BE USED OR LOADED INTO THE PUMP THE DEVICE(S) MAY HAVE CAUSED OR CONTRIBUTED TO: POTENTIAL FOR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950210 UNSPECIFIED BD PRI TUBING PRIMARY TUBING SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other