BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIPO ADMON SOL PEEL POUCH

    MDR report key: 2032861 · Received March 29, 2011

    Report

    Report Number
    6000001-2011-02324
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 03/18/2011. ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS SUBMITTED FOR VISUAL EXAMINATION AND FUNCTIONAL TESTING. AFTER EVALUATING THE RESULTS OF THESE TESTS, THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO VARIATION IN THE MOLDING PROCESS. THE ROLLER CLAMP MOLD FAILED RESULTED IN GAUGE VARIATION WITHIN THE PART THAT HOLDS THE ROLLER. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A SOLUTION ADMINISTRATION SET THAT HAD A DEFECTIVE ROLLER CLAMP. ACCORDING TO THE REPORT, DESPITE THE ROLLER CLAMP BEING CLOSED, IT LEAKS AND IS NOT FUNCTIONAL. THE CONDITION WAS IDENTIFIED DURING PRIMING AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUIPO ADMON SOL PEEL POUCH SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CALI SE11BH6

    Patients

    Seq Age Sex Outcome Treatment
    1