BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2100816 · Received May 24, 2011

    Report

    Report Number
    6000001-2011-04459
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K042936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN UNKNOWN AMOUNT OF FLO-LINK MICROBORE CATHETER EXTENSION SETS IN WHICH REDUCTION IN FLOWS OCCURRED. ACCORDING TO THE REPORT, THE CUSTOMER STATED THAT THEY HAVE CONCLUSIVE PROOF THAT THESE SETS SLOW DOWN SOLUTION FLOWRATES AND IN AN EMERGENCY, THAT CAN BE CRITICAL. THE ISSUE WAS NOTED PRIOR TO PRODUCT USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1