BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2173474 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13560
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE ATTACHED TO A NON BAXTER SET. THE SAMPLE WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED. THE SAMPLE HAD BEEN PRIMED. VISUAL INSPECTION UNDER A MICROSCOPE SHOWED THAT THE OUTLET PORT OF THE FILTER HOUSING WAS BROKEN OFF OF THE FILTER HOUSING OUTLET. IT WAS ALSO NOTED THAT THE BLUE SLIDE CLAMP WAS MISSING. THERE WAS SOME SURFACE DAMAGE TO THE FILTER HOUSING NEAR THE FILTER HOUSING OUTLET END THAT WAS OBSERVED TO BE BROKEN. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) REGARDING THE CLEARLINK EXTENSION SET WITH 0.22 MICRON FILTER, IN WHICH THE BOTTOM OF THE FILTER SEPARATED FROM THE TUBING ON AN UNKNOWN DATE. THERE WAS NO MEDICATION BEING INFUSED, ONLY MAINTENANCE FLUID. THE CUSTOMER SAID THE FLUID IN THE SET IS A RED/ORANGE COLOR AND MAY BE BLOOD THAT IS DILUTED IN THE MAINTENANCE FLUID. THE NURSE THAT WITNESSED THE EVENT CLAMPED THE TUBING IMMEDIATELY AND CONFIRMED THERE WAS LESS THAN 1ML OF BLOOD THAT BACKED UP INTO THE TUBING. THE LINE WAS FLUSHED AND THE TUBING WAS CHANGED, THEN THE INFUSION WAS COMPLETELY WITHOUT ANY FURTHER INCIDENT. A HOSPIRA OMNI PUMP WAS BEING USED. IT IS UNKNOWN HOW LONG INTO THE INFUSION THE SEPARATION WAS OBSERVED. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOSPIRA OMNI PUMP, MAINTENANCE FLUID