BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3130675 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13437
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER. THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED PRODUCT CODE 2H8671 AND 1 UNUSED/COMPANION SAMPLE OF PRODUCT CODE 2H8671, LOT R12L04079 WAS RECEIVED BY BAXTER PRODUCT ANALYSIS LABORATORY FOR EVALUATION. THE USED SAMPLE ARRIVED OUT OF THE PACKAGE AND PRIMED. THE COMPANION SAMPLE ARRIVED IN A SEALED POUCH. VISUAL INSPECTION SHOWED NO OBVIOUS DEFECTS. THE USED SAMPLE WAS ATTACHED TO AN IN HOUSE 10ML SYRINGE FILLED WITH REVERSE OSMOSIS WATER. THE PLUNGER OF THE SYRINGE WAS THEN MANUALLY DEPRESSED. THIS SHOWED LEAK AT THE OUTLET END CAP OF THE FILTER HOUSING. CLOSER VISUAL INSPECTION SHOWED THAT THE LOCATION OF THE LEAK IS LOCATED AT THE AIR VENT. THE UNUSED/COMPANION SAMPLE WAS ALSO TESTED USING THE SAMPLE METHOD. NO LEAKS WERE DETECTED. THIS REPORT FOR LEAKS WAS CONFIRMED DUE TO THE OBSERVATION OF A LEAK LOCATED AT THE AIR VENT. THE CAUSE IS UNDETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLEARLINK EXTENSION SET WAS BEING FLUSHED A LEAK WAS DETECTED AT THE SITE WHERE THE FILTER CONNECTS TO THE TUBING. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231370 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION