BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV167,24 PACK

    MDR report key: 1880584 · Received October 22, 2010

    Report

    Report Number
    6000001-2010-04441
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "BROKEN TUBING AT THE BLUE WINGED CAP AND LUER LOCK" WAS NOT CONFIRMED. HOWEVER, THE DELIVERY TUBING WAS FOUND CUT APPROXIMATELY 2 INCHES FROM THE TOP OF THE COIL CAP. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO BAXTER THAT AN INTERMATE LV 167 DEVICE WAS FOUND WITH ITS TUBING BROKEN AT THE LUER LOCK. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THIS CONDITION WAS DISCOVERED BEFORE USE. 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 LV167,24 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10D042

    Patients

    Seq Age Sex Outcome Treatment
    1