BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3170993 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15431
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - SAN JUAN
    Product Code
    FPA
    PMA / PMN Number
    K981792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. 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. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK PACLITAXEL SET LEAKED FROM THE FILTER AREA DURING INFUSION. THE DEVICE WAS BEING USED WITH AN ONCOLOGICAL DRUG. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271200 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SAN JUAN R12H28117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ONCOLOGICAL DRUG