BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2171933 · Received July 22, 2011

    Report

    Report Number
    6000001-2011-13436
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: SAMPLE WAS NOT RECEIVED BY BAXTER FOR EVALUATION. NO FLOW WAS NOT CONFIRMED DUE TO SAMPLE UNAVAILABILITY. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. NO ROOT CAUSE WAS IDENTIFIED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT OF SIX (6) BOTTLES OF INFUSOR LV 10 MODELS WHICH WOULD NOT FLOW. THE CUSTOMER MIXED "ZOSYN" WITH NORMAL SALINE FOR A PATIENT, AND "IT APPEARS TO HAVE PRECIPITATED OUT". THE SIX (6) SAMPLES ARE AVAILABLE FOR EVALUATION. THIS IS REPORT 5 OF 6. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11B051

    Patients

    Seq Age Sex Outcome Treatment
    1