BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 5157541 · Received October 16, 2015

    Report

    Report Number
    1416980-2015-39250
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Date of Event
    June 9, 2015
    Report Date
    December 1, 2015
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS A (B)(6) AND THE EVENT OCCURRED IN THE NEONATAL INTENSIVE-CARE UNIT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW TEST REVEALED A LEAK AT THE AIR VENT HOLE IN THE MALE OUTLET END OF THE CASING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK EXTENSION SET LEAKED FROM ITS AIR FILTER. THE USER NOTICED THAT THE "SCREW ON PORTION SLID DOWN ON (THE) TUBING" DURING THE LEAK. THE REPORT INDICATED THAT THIS OCCURRED DURING INFUSION OF TOTAL PARENTERAL NUTRITION SOLUTION USING A PERIPHERALLY INSERTED CATHETER LINE AND A NON-BAXTER PUMP. THE PUMP REPORTEDLY HAD NO ISSUES. PRIOR TO THE EVENT, THE FILTER WAS PLACED VERTICALLY AND NO ISSUES WERE VISUALLY NOTICED WITH THE SET. 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
    685738 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R14K15034

    Patients

    Seq Age Sex Outcome Treatment
    1