BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2939344 · Received February 1, 2013

    Report

    Report Number
    1416980-2013-02663
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE SAMPLE WAS NOT AVAILABLE SO THE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER NOTIFIED BAXTER CORPORATE PRODUCT SURVEILLANCE (CPS) THAT AIR WAS OBSERVED IN THE PRESSURE PUMP OF A CL BLOOD SET Y-TYPELARGE 170-260 FILTER HAND PUMP AFTER INFUSION. IT WAS REPORTED THAT THE TUBING RAN DRY WHEN THE BAG WAS SWITCHED OUT. DURING A FOLLOW-UP WITH THE CUSTOMER, IT WAS STATED THAT THE NURSES WERE NOT REGULATING FLOW PER THE LABEL COPY. THE NURSE WAS NOT PROPERLY SEATING THE TUBING IN THE REGULATING ROLLER CLAMP. SINCE THE EVENT, THERE HAS BEEN A RETRAINING AND NO FURTHER ISSUES HAVE OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44599 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1