BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE 5.0-7.0

    MDR report key: 1880602 · Received October 22, 2010

    Report

    Report Number
    6000001-2010-04443
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K051253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED; LEAKAGE WAS OBSERVED AT THE JUNCTION OF THE TUBING AND THE MULTIRATE MODULE POST. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DUE TO AN ERROR MADE DURING THE MANUFACTURING PROCESS. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) REGIONAL ANALGESIA INFUSOR WITH PATIENT CONTROL MODULE WAS LEAKING NEAR THE FLOW CONTROL. THE DEVICE WAS FILLED WITH OPIATES AND LOCAL ANESTHETIC. THE LEAK WAS DISCOVERED DURING STORAGE AFTER PREPARATION. NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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