BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE MULTIRATE INFUSOR LV2,3,512 PACK

    MDR report key: 1984270 · Received February 10, 2011

    Report

    Report Number
    6000001-2011-00856
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 30, 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 DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK CONDITION CONFIRMED. A LEAK TEST WAS SUBSEQUENTLY PERFORMED ON THE UNIT. DURING FILL, LEAK WAS IMMEDIATELY NOTED AT THE JUNCTION OF THE TUBING AND THE MULTIRATE MODULE. THE LEAK WAS CAUSED BY A PARTIALLY BROKEN TUBING. NO OTHER LOCATION OR CAUSE OF LEAK WAS FOUND ON THE UNIT. THE ROOT CAUSE OF THIS DEFECT COULD NOT BE DETERMINED. 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 AN INFUSOR LV 2 DEVICE WAS LEAKING AFTER FILLING. THE DEVICE HAD BEEN FILLED WITH AN UNKNOWN DRUG WHEN THE LEAK WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE MULTIRATE INFUSOR LV2,3,512 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10G028

    Patients

    Seq Age Sex Outcome Treatment
    1