BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2073177 · Received April 29, 2011

    Report

    Report Number
    6000001-2011-03304
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    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). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT CONFIRMED THE REPORTED CONDITION OF A LEAK, OBSERVED AT THE CONNECTION OF THE BLUE WINGED LUER CAP. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR; THE CAP WAS NOT SECURELY TIGHTENED. AFTER THE CAP WAS SECURELY TIGHTENED AND THE CLAMP CLOSED, THE LEAKAGE COMPLETELY STOPPED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (B)(4) PRODUCT SURVEILLANCE RECEIVED A COMPLAINT THAT ONE (1) CE INTERMATE LV 100 WAS LEAKING AT THE BLUE WINGED CAP AFTER BEING FILLED WITH PAMIDRONATE. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10N008

    Patients

    Seq Age Sex Outcome Treatment
    1 PAMIDRONATE