BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE MULTIRATE INFUSOR LV2,3,512 PACK

    MDR report key: 2061600 · Received April 18, 2011

    Report

    Report Number
    6000001-2011-02947
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4) A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE MULTIRATE INFUSOR EXPERIENCED A "BALLOON" LEAK INSIDE THE DEVICE DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT AND, THEREFORE, NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE MULTIRATE INFUSOR LV2,3,512 PACK PUMP, INFUSOR, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10M089

    Patients

    Seq Age Sex Outcome Treatment
    1