BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE 5.0-7.0

    MDR report key: 1972355 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00464
    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). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED. THE REPORTED CONDITION OF A RESERVOIR RUPTURE WAS NOT CONFIRMED. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(6) THAT THE RESERVOIR OF ONE (1) REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE HAD RUPTURED DURING FILLING. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH NAROPIN. THERE WAS NO PATIENT INVOLVEMENT. 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 NAROPIN