BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR

    MDR report key: 4110027 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32791
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN, ACCESS ONE-LINK SET WAS INVOLVED IN A NO FLOW INCIDENT. THIS OCCURRED DURING PATIENT INFUSION OF NORMAL SALINE AND EITHER CARBOPLATIN (NON-BAXTER PRODUCT) OR A DIFFERENT CHEMOTHERAPEUTIC (NON-BAXTER PRODUCT). THE SETUP DURING WHICH THIS OCCURRED INVOLVED THE CHEMOTHERAPY BAG, THE NORMAL SALINE BAG, A NON-BAXTER IV SET, AND A PRIMARY CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET (BAXTER PRODUCT). THE REPORTER STATED THAT THE CHEMOTHERAPEUTIC WAS BEING RUN THROUGH THE SECONDARY LINE WHILE THE SALINE WAS BEING RUN THROUGH THE PRIMARY LINE. THE CHEMOTHERAPEUTIC BAG WAS HUNG ABOVE THE SALINE BAG USING A HANGER. AFTER THIS OCCURRED, THE LINE WAS REPRIMED SO THE PATIENT COULD COMPLETE THE INFUSION. THERE WAS NO 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
    590059 SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 CARBOPLATIN OR HERCEPTIN BAG| CLEARLINK CONTINU FLO SOLUTION SET DUOVENT| NORMAL SALINE| BD SECONDARY IV SET