BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2883974 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07958
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 30, 2012
    Manufacturer
    PLASTI ESTERIL, S.A. DE C.V.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WASN'T CONFIRMED DURING EVALUATION. ACTUAL DEVICE WAS AVAILABLE FOR EVALUATION. NO DEFECT WAS OBSERVED DURING VISUAL INSPECTION. THE UNIT WAS TESTED WITH DRIP TEST METHOD. THE DRIP TEST ALLOWED THE FLOW OF LIQUID THROUGH THE CHAMBER AND THE PIPE, PRESENTED NO PROBLEM OF OBSTRUCTION. THE TEST INTEGRITY NOT PRESENT LEAK IN ANY OF THE PARTS ASSEMBLED. NO OTHER TEST WAS PERFORMED. THE DEVICE WAS WORKING WITHIN SPECIFICATION. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF AN EXASET FOTOSENSIBLE SOLUTION ADMINISTRATION SET IN WHICH THE OPERATOR DETECTED NO FLOW OF UNKNOWN MEDICATION. THE REPORTED CONDITION OCCURRED DURING INFUSION. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED 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 PLASTI ESTERIL, S.A. DE C.V. 68TDE

    Patients

    Seq Age Sex Outcome Treatment
    1