BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3943507 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23196
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL
    Product Code
    FPA
    PMA / PMN Number
    K123874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, PHOTOGRAPHS OF THE DEVICE WERE RECEIVED. EXAMINATION OF THE PHOTOGRAPHS NOTED THAT THE DRIP CHAMBER WAS SEPARATED FROM THE BURETTE END CAP, VERIFYING THE REPORTED CONDITION. DROPLETS OF SOLUTION WERE ALSO IDENTIFIED ON THE INTERIOR SURFACE OF THE DRIP CHAMBER. THE CAUSE WAS DETERMINED TO DUE TO A MANUFACTURING ISSUE. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK SOLUTION SET FELL APART. THE REPORTER STATED THAT WHEN THE NURSE ADJUSTED THE FLUID FLOW, THE SET FELL APART. THIS OCCURRED DURING INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422274 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL DR13K01019

    Patients

    Seq Age Sex Outcome Treatment
    1