BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 LEAD SOLUTION ADMINISTRATIONSET

    MDR report key: 2063515 · Received April 19, 2011

    Report

    Report Number
    6000001-2011-02980
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS SUBMITTED FOR FUNCTIONAL TESTING USING A METHYLENE BLUE SOLUTION TO DETECT ANY LEAKAGE CAUSED BY A FAULTY CLAMP. THIS ANALYSIS CONFIRMED THAT THE CLAMP IS DEFECTIVE. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE REPORTED CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A 2-LEAD SOLUTION ADMINISTRATION SET IN WHICH THE CLAMP DID NOT WORK - IT WAS IMPOSSIBLE TO CLOSE. THE CONDITION OCCURRED WHILE ADMINISTERING AN UNKNOWN ANTIBIOTIC ON A PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 LEAD SOLUTION ADMINISTRATIONSET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10J05V067M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ANTIBIOTIC