BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 1820451 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02879
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF AN INTERMATE LV 100 DEVICE WHICH WAS LEAKING FROM THE BLUE WINGED LUER CAP WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION. UPON RECEIPT BY BAXTER, SOLUTION WAS NOTED IN THE BAG THAT CONTAINED THE DEVICE, WHICH SUGGESTED LEAKAGE MUST HAVE OCCURRED. HOWEVER, NO SIGNS OF LEAK WERE OBSERVED DURING PRODUCT TESTING. A POTENTIAL CAUSE HAS BEEN IDENTIFIED FOR COMPLAINTS OF LEAKS INVOLVING THE BLUE WINGED CAP AND LUER BODY CONNECTIVITY. POTENTIALLY, LEAKS FROM THIS AREA COULD BY CAUSED BY MATERIAL BUILD UP IN THE CORE PINS, DURING MANUFACTURING, CAUSING SURFACE ROUGHNESS ON THE WINGED LUER CAP. THIS DEVICE IS A SINGLE USE DEVICE AND WILL BE DISCARDED. A BATCH REVIEW WAS PERFORMED REVEALING AN EXCEPTION REPORT WAS DOCUMENTED FOR THIS LOT. HOWEVER, THE ISSUE ASSOCIATED WITH THIS EXCEPTION REPORT IS NOT CURRENTLY SEEN AS CONTRIBUTING TO THE CUSTOMER REPORTED AND CONFIRMED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4).PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LARGE DRY SCAB WAS NOTED AROUND THE POCKET OF OF THIS PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AN INFECTION WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, NO ADDITIONAL INVENTION HAS BEEN PERFORMED, AND THIS DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INTERMATE LV 100 DEVICE WAS FOUND TO BE LEAKING FROM THE BLUE WINGED LUER CAP. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THIS CONDITION WAS DISCOVERED AFTER THE DEVICE WAS FILLED WITH 240ML OF 0.9% SODIUM CHLORIDE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 100, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10E035

    Patients

    Seq Age Sex Outcome Treatment
    1