BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2120507 · Received June 10, 2011

    Report

    Report Number
    6000001-2011-07469
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE RESULTS WERE SATISFACTORY; ALL COMPONENTS WERE PRESENT, IN THE RIGHT POSITION, AND COMPLETE. THE SAMPLE WAS SUBMITTED TO AN UNDERWATER LEAK TEST WHICH REVEALED THE ROLLER CLAMP WAS DEFECTIVE AS IT ALLOWED LEAKAGE INTO THE ASSEMBLY. THE SAMPLE WAS THEN SUBMITTED TO A PULL TEST (5 LBS 10 SECONDS WAS APPLIED TO THE COMPONENTS BONDING ASSEMBLY) AND THE COMPONENTS DID NOT SEPARATE. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO A VARIATION IN THE HEIGHT OF THE CAVITY MOLD OF THE ROLLER CLAMP. THE MANUFACTURING FACILITY HAS IDENTIFIED CORRECTIVE ACTIONS TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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 BURETROL SOLUTION SET IN WHICH THE ROLLER CLAMP IS MISASSEMBLED AND ALLOWS THE PASSAGE OF SOLUTION - DOES NOT CLOSE. THE CONDITION WAS IDENTIFIED DURING SET-UP BEFORE PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED 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 - CALI SX11BV2

    Patients

    Seq Age Sex Outcome Treatment
    1