BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2981490 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04847
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE ACTUAL DEFECTIVE UNIT WAS AVAILABLE AT THE PLANT FOR EVALUATION. DURING VISUAL INSPECTION WAS OBSERVED A PUNCTURE/ BROKEN BURETTE CHAMBER. PRESSURE TEST WAS PERFORMED AT 8PSI AND THE UNIT LEAKS WHERE THE DEFECT WAS IDENTIFIED DURING VISUAL INSPECTION. FUNCTIONAL TEST WAS ALSO PERFORMED. TIP PROTECTORS WERE REMOVED, CLAMPS WERE CLOSED. UNIT WAS CONNECTED TO A SOLUTION CONTAINER CLAMP WERE OPENED, PROCEED WITH THE PRIMING PROCESS. UNIT FAILED TO FUNCTIONAL TEST DUE A LEAK IN THE BURETTE. ADDITIONAL INFORMATION: SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED FOR EVALUATION. FOLLOWING EVALUATION OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAK WAS OBSERVED FROM THE DRIP CHAMBER OF A FOUR LEAD TUR IRRIGATION SET DURING OPERATION. THERE WAS A PATIENT INVOLVEMENT BUT NO PATIENT INJURY/ADVERSE EVENT OR MEDICAL INTERVENTION IN ASSOCIATION WITH THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84739 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - AIBONITO UR10D09142

    Patients

    Seq Age Sex Outcome Treatment
    1