BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 1943228 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06532
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    April 8, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER INITIALLY REPORTED THAT THE SAMPLE IS AVAILABLE. HOWEVER, THE SAMPLE WAS INADVERTENTLY DISCARDED BEFORE BEING SENT TO BAXTER. THEREFORE, THE DEVICE WAS NOT EVALUATED, THE REPORTED CONDITION COULD NOT BE CONFIRMED, AND NO ROOT CAUSE WAS IDENTIFIED. PER THE CUSTOMER, THE LOT NUMBER IS UNKNOWN. THEREFORE, A BATCH REVIEW COULD NOT BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. REPORTED COMPLAINTS OF LEAK SHOW AN UNFAVORABLE TREND YEAR OVER YEAR, WITH ANNUAL COMPLAINT INCIDENTS PER MILLION INCREASING FROM 40 IN 2009 TO 369 IN 2010. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT 2 INFUSOR LV 100 DEVICES WERE LEAKING BEFORE USE. THIS IS REPORT NUMBER 2 OF 2. THE DEVICE WAS FILLED WITH 90 MILLIGRAMS PAMIDRONATE WHEN THE LEAKS WERE OBSERVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INTERMATE LEAKED INTO ITS PACKAGING BEFORE PATIENT USE. THE DEVICE WAS FILLED WITH A SOLUTION OF 90 MG PAMIDRONATE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THE SAMPLE IS NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1