BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4093258 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31497
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AIR IN THE LINE OF AN ACCESS CHEMOTHERAPY SET. THIS OCCURRED DURING PATIENT INFUSION OF AN UNSPECIFIED CHEMOTHERAPEUTIC SOLUTION USING A NON-BAXTER PUMP AND ADDITIONAL NON-BAXTER SETS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571121 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS

    Patients

    Seq Age Sex Outcome Treatment
    1 LAMERIS ARGUS PUMP| CHEMOTHERAPEUTIC SOLUTION| SENDAL SET| BRAUN SET