BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2842918 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05781
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A 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). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT WAS CONFIRMED FOR SEPARATION. THE ROOT CAUSE IS UNDETERMINED. VISUAL INSPECTION FOUND THAT THE MALE LUER WAS SEPARATED FROM THE TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER HEALTHCARE ONE CLEARLINK CONTINU-FLO SOLUTION SET IN WHICH THE SOFT TUBING PULLED APART FROM THE HARD LUER, WHICH WAS CONNECTED DIRECTLY TO THE PATIENT'S IV CATHETER. THE CUSTOMER STATED THAT ONLY UNSPECIFIED MAINTENANCE FLUIDS WERE BEING ADMINISTERED AT THE TIME OF THE EVENT TO THE PATIENT WHO WAS SCHEDULED TO RECEIVE CHEMOTHERAPY FOR AN UNSPECIFIED CONDITION. PER THE REPORT, THE PROBLEM WAS DETECTED SHORTLY AFTER CONNECTING, WHEN THE PATIENT MOVED HER ARM. THE CUSTOMER STATED THAT THERE WAS NO STRETCHING OR HARD PULL ON THE TUBING. THE CUSTOMER STATED THAT NO HARM IS REPORTED FOR PATIENT, WHO WAS ALERT, ORIENTATED AND COOPERATIVE DURING THE EVENT. PER THE REPORT, THE TUBING WAS CHANGED IMMEDIATELY; THE NEW TUBING WAS FLUSHED AND TREATMENT CONTINUED WITHOUT FURTHER EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12F13113

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR IV CATHETER, UNKNOWN MAINTENANCE IV SOLUTIONS