BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2093469 · Received May 18, 2011

    Report

    Report Number
    6000001-2011-04170
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION CONTAINING APPROXIMATELY 150 ML OF SOLUTION IN THE RESERVOIR. VISUAL EXAMINATION OF THE UNIT CONFIRMED THE REPORTED CONDITION OF A LEAK, OBSERVED AT THE CONNECTION OF THE BLUE WINGED LUER CAP. THE CAP WAS NOTED TO BE TIGHTENED ON THE LUER. THE ROOT CAUSE OF THE LEAK CONDITION WAS DELAMINATION (MATERIAL BUILD-UP) ON THE CORE PINS DURING MANUFACTURING, CAUSING SURFACE ROUGHNESS ON THE WINGED LUER CAP. THE CORRECTIVE ACTION WAS TO CHANGE THE CORE PINS FROM ROUND POLISH TO DRAW POLISH. IN ADDITION, AN INSPECTION PROTOCOL WAS IMPLEMENTED TO CROSS-SECTION ONE COMPLETE SHOT EVERY EIGHT-HOUR SHIFT AND PERFORM AN INSPECTION OF THE INSIDE SURFACE OF THE PART. BAXTER ACQUIRED NEW MATERIAL CORE PINS THAT WILL PREVENT DELAMINATION. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. ADDITIONAL INFORMATION: 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) PRODUCT SURVEILLANCE RECEIVED A COMPLAINT FROM BAXTER CIVA THAT A LEAK WAS NOTED FROM THE BLUE WINGED LUER CAP OF AN INTERMATE UNIT. THE PROBLEM WAS NOTED AFTER FILLING; THERE WAS NO PATIENT INVOLVEMENT. SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11A039

    Patients

    Seq Age Sex Outcome Treatment
    1