BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE 5.0-7.0

    MDR report key: 1875255 · Received October 19, 2010

    Report

    Report Number
    6000001-2010-04297
    Event Type
    Malfunction
    Date Received
    October 19, 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).THERE IS NO SAMPLE AVAILABLE TO BAXTER FOR EVALUATION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW HAS BEEN PERFORMED. ALL RELEASE CRITERIA HAVE BEEN MET FOR THE PRODUCTION OF THIS LOT.BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER FINLAND TO REPORT A LEAK OF A MULTIRATE BOLUS INFUSOR. THE LEAK WAS DISCOVERED AFTER PREPARATION AND DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH 40 ML OF 10 MG/ML NAROPIN, 20 ML OF 50 MICROGRAMS/ML OF FENTANYL-HAMELN, AND 210 ML OF 9 MG/ML SODIUM CHLORIDE WITH A TOTAL VOLUME 270 ML. THE SOLUTION WAS NOT FILTERED BEFORE FILLING. THE FILLING PORT AND LUER LOCK CAPS WERE CLOSED AND THE BLADDER DID NOT APPEAR DAMAGED. NO SHARP OBJECTS WERE USED TO OPEN THE OVERPOUCH OF THE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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