BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2132972 · Received June 17, 2011

    Report

    Report Number
    6000001-2011-07981
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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) THAT ON (B)(6) 2011, THE FOLLOWING PROBLEM OCCURRED WITH 2 MIRAFILTER IV EXTENSION SETS. TWO INFUSIONS OF "VECTIBIX" WERE PREPARED IN A LAMINAR FLOW CABINET, WITH ALREADY A PRE-PRIMED SET OF EMC3294A ATTACHED. THE INFUSIONS WERE RETURNED TO THE HOSPITAL PHARMACY, AFTER NOTICING A LEAK, NEAR THE LUER LOCK JUNCTION WITH THE FILTER. BOTH INFUSIONS WERE PREPARED BY TWO DIFFERENT PERSONS. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10L30V691M

    Patients

    Seq Age Sex Outcome Treatment
    1 VECTIBIX