BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2991345 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05401
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED. TWO USED SAMPLES AND TWELVE COMPANION (UNUSED) SAMPLES WERE AVAILABLE AT THE PLANT FOR EVALUATION. NO DEFECT WAS OBSERVED DURING VISUAL INSPECTION AND UNDER WATER TEST IN ALL OF THE SAMPLES. ALL OF THE COMPANION SAMPLES WERE TESTED USING FLOW TEST AND NO DEFECT WAS FOUND. TWO USED SAMPLES WERE TESTED UNDER REAL TIME SITUATION. BOTH OF THE SETS PRIMED AND FLOWED NORMALLY WITH NO LEAKS FOUND. ALL THE SETS WERE WORKING WITHIN SPECIFICATION. (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A SAMPLE HAS BEEN REQUESTED BUT NOT YET RECEIVED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER CANADA THAT WHILE THE NURSE WAS PROGRAMMING THE COLLEAGUE PUMP, THE DEVICE HAD SIGNIFICANT AMOUNT OF AIR IN THE LINE AND THE PUMP DID NOT ALARM. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS REPORT OF PATIENT INVOLVEMENT, AND NO REPORT OF PATIENT INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96209 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12J22059

    Patients

    Seq Age Sex Outcome Treatment
    1