BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2862957 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06672
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING SAMPLE EVALUATION. ONE DEFECTIVE SAMPLE WAS RETURNED AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED SPOTS ON THE TUBING. NO OTHER TEST WAS PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE THEATRE MANAGER OF THE FACILITY REPORTED TO BAXTER (B)(4) OF A CONTINU-FLO SOLUTION ADMINISTRATION SET WITH THREE LUER ACTIVATED VALVES IN WHICH OPERATOR OBSERVED VISIBLE SPOTS ON/IN THE TUBING. THE REPORTED CONDITION OCCURRED DURING PRIMING THE SET WITH AN UNKNOWN SOLUTION. THE SPOTS DID NOT APPEAR TO MOVE WITH THE SOLUTION DURING PRIMING. THERE IS NO REPORT OF PATIENT INVOLVEMENT, 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
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1