BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3272891 · Received August 8, 2013

    Report

    Report Number
    1416980-2013-21276
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K123874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL, MICROSCOPIC, AND SPECTROSCOPIC INSPECTION CONFIRMED A PARTICLE IN THE BURETTE CHAMBER TO BE A 2.4 MM LONG SLIVER OF WHITE ACRYLONITRILE BUTADIENE STYRENE (ABS) MATERIAL. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT SOURCE OF THE ABS MATERIAL AND WHETHER IT DERIVED FROM THE MATERIAL OF THE SPIKE OR BURETTE CAPS, OR SOME OTHER SOURCE. THEREFORE, THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FIBROUS MATERIAL WAS OBSERVED INSIDE THE BURETTE OF AN INTERLINK BURETROL SET. THIS OCCURRED BEFORE PATIENT USE OF THE DEVICE. THE REPORTER STATED THAT THE FIBER WAS OBSERVED AFTER FILLING THE SET WITH TOTAL PARENTERAL NUTRITION (TPN) FROM A NON-BAXTER SOLUTION BAG. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372755 ACCESS SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FPA BAXTER HEALTHCARE - AIBONITO UR10J13118

    Patients

    Seq Age Sex Outcome Treatment
    1