BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3033867 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08320
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    FPB
    PMA / PMN Number
    K113227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION WAS CONFIRMED. THE SAMPLE WAS VISUALLY INSPECTED AND IT WAS DETERMINED THAT THE SEPTUM OF THE Y-SITE WAS SEPARATED FROM THE Y-SITE HOUSING (INVERTED SEPTUM), CAUSING THE SET TO LEAK. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS NOT PERFORMED, AS A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK MICRON FILTER EXTENSION SET BROKE. DURING INFUSION OF AN UNKNOWN ANTIBIOTIC A PIECE OF THE SET, POSSIBLY NEAR THE SLIDE CLAMP, "POPPED OFF." THE NURSE NOTICED THAT THE BED WAS WET WHEN SHE WENT TO TURN OFF THE PUMP. THE ANTIBIOTICS WERE READMINISTERED TO THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135904 ACCESS FILTER, INFUSION LINE FPB BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ANTIBIOTICS