BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2855054 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06352
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 15, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE ACTUAL SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE TUBE WAS DISCONNECTED FROM THE CHAMBER. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO LOW INSERTION BY THE MACHINE. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE U.S. AND DOES NOT HAVE A 510K NUMBER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTIONS: THE PREVIOUS DATE OF (B)(4) 2012 ON THE INITIAL REPORT WAS INCORRECTLY CHOSEN. AFTER FURTHER INVESTIGATION, THE REPORTED CONDITION WAS DETERMINED TO BE A REPORTABLE MALFUNCTION ON(B)(4) 2012. THE DATE HAS BEEN CORRECTED TO (B)(4) 2012.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A FLO-GARD IV SOLUTION ADMIN SET IN WHICH THE TUBE DISCONNECTED FROM THE CHAMBER. THE EVENT OCCURRED DURING PRIMING OF NORMAL SALINE. 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 - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1