BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3143437 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14139
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED. VISUAL INSPECTION OF THE PHOTO CONFIRMED THE PRESENCE OF AIR IN THE FILTER HOUSING. THE CAUSE WAS UNABLE TO BE DETERMINED. A CAPA WAS OPENED TO ADDRESS THE ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. BAXTER RECEIVED A PHOTO OF THE SAMPLE FOR EVALUATION. INITIAL PHOTOGRAPHIC EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK FILTER SET WAS FOUND WITH AIR BUBBLES AND CONDENSATION. ACCORDING TO THE REPORT, THE BUBBLES AND CONDENSATION WERE FOUND INSIDE THE FILTER DURING PATIENT THERAPY WHILE INFUSING A TOTAL PARENTERAL NUTRITION (TPN) SOLUTION. THE EXTENSION SET WAS REMOVED AND REPLACED AS A RESULT OF THE INCIDENT. THE EVENT OCCURRED IN THE PRENATAL INTENSIVE CARE UNIT (PICU). THERE WAS PATIENT INVOLVEMENT, HOWEVER, 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
    245309 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12K21067

    Patients

    Seq Age Sex Outcome Treatment
    1 TPN SOLUTION