BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE 5.0-7.0

    MDR report key: 1973126 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00478
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K051253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "LEAKING AT THE BLUE WINGED CAP" WAS CONFIRMED. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. NO OTHER OBSERVATION WAS FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE WAS OBSERVED LEAKING AT THE BLUE WINGED CAP AFTER FILLING. THE DEVICE WAS FILLED WITH NAROPIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 7 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE 5.0-7.0 PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10E065

    Patients

    Seq Age Sex Outcome Treatment
    1 NAROPIN