BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM2400 VALVE SET

    MDR report key: 1435427 · Received February 26, 2009

    Report

    Report Number
    1419106-2009-00004
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    November 29, 2008
    Report Date
    December 1, 2008
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE COMPLAINT, IT WAS FOUND THAT THE 724 VALVE SET WAS NOT RETURNED BY THE CUSTOMER, AND THE LOT NUMBER IS UNK, BUT TWO PICTURES OF THE DAMAGED 724 VALVE SET WERE SENT. IN THE PICTURES, IT APPEARS THE VALVE CORE FOR PORT #3 WAS ORIENTED AT AN ANGLE, ABOUT 15 DEGREES, TO THE OTHER 23 CORES, AND THAT THE CORE IS DAMAGED AS WELL. REVIEW OF THE COMPLAINT REVEALS THAT THE TPNS MADE WITH THIS VALVE SET WERE DISCARDED. THE CUSTOMER REPORTED THAT THERE WERE NO PTS INVOLVED, AND NO ADVERSE EVENTS WERE ASSOCIATED WITH THIS ISSUE. TESTING: A 724 VALVE SET, WITH A VALVE CORE AT APPROXIMATELY THE SAME ORIENTATION AS THE CUSTOMER'S PICTURE, WAS LOCKED ON AN EM2400 COMPOUNDER, AND THE VALVE CORE DAMAGE IN THE PICTURE WAS RE-PRODUCED. A NEW 724 VALVE SET WAS THEN, WITH A MIS-ALIGNED CORE AS REPORTED BY THE CUSTOMER, PLACED ON THE TOOL THAT BAXA USES TO CONFIRM THAT ALL OF THE CORES ARE ORIENTED CORRECTLY. THE TEST WAS NOT PASSED. ANY 724 VALVE SETS THAT DO NOT PASS THIS TEST ARE DISCARDED, AND ALL 724S ARE TESTED IN THIS MANNER. THEREFORE, IT CAN BE CONCLUDED THAT THE VALVE CORE MIS-ALIGNMENT OCCURRED AFTER THE 724 VALVE SET LEFT BAXA. CONCLUSION: THE REPORTED ISSUES WERE OBSERVED BY THE CUSTOMER AFTER BEING PLACED ON THE EM2400 COMPOUNDER AND THEREFORE, IT IS UNK WHEN THE CORE ORIENTATION/DAMAGE ISSUES OCCURRED. THE ROOT CAUSE OF THE REPORTED ISSUE IS UNK.

    Description of Event or Problem · 1

    UPON REVIEW OF THE MAUDE DATABASE BY BAXA CORPORATION'S QUALITY DEPARTMENT, MEDWATCH (B)(4) WAS DISCOVERED. THIS MDR IS FILED PER BAXA'S PROCEDURE TO SUBMIT AN MDR FOR ALL MEDWATCH FORMS SUBMITTED. THIS MEDWATCH WAS DISCOVERED IN THE MAUDE DATABASE ON 01/27/2009 AND THE ASSOCIATED COMPLAINT WITHIN BAXA'S CUSTOMER COMPLAINT SYSTEM WAS IDENTIFIED. THE CUSTOMER DID NOT INDICATE THAT THEY INTENDED TO SUBMIT A MEDWATCH AT THE TIME THE COMPLAINT WAS REPORTED. COMPLAINT INFO: IT WAS REPORTED THAT ON (B)(6) 2008 A SODIUM PHOSPHATE PRODUCT VIAL WAS FOUND EMPTY AFTER THREE TPNS WERE PUMPED. THE TOTAL SODIUM PHOSPHATE FOR THE THREE TPNS SHOULD HAVE ONLY AMOUNTED TO 2 MLS OF INGREDIENT PLUS "6-8MLS OF PRIMING VOLUME." IN SPEAKING WITH THE FACILITY PHARMACIST, THE TOTAL SODIUM PHOSPHATE VIAL VOLUME WAS 50MLS. AT THIS POINT, THE PHARMACIST BELIEVED THERE SHOULD BE APPROXIMATELY 40MLS OF INGREDIENT LEFT IN THE VIAL. THE FACILITY PHARMACIST DOES NOT KNOW FOR SURE IF THE TECHNICIAN RUNNING THE COMPOUNDER WAS THEN ASKED TO CHANGE OUT THE VIAL OR IF A BUBBLE ALARM WAS RECEIVED. THE 724 VALVE SET WAS TURNED OVER AND THE VALVE CORE #3 FOR THE PORT SODIUM PHOSPHATE IS ON WAS FOUND TO BE SLIGHTLY DENTED AND NOT ALIGNED WITH THE OTHER 23 PORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EM2400 VALVE SET EM2400 VALVE SET LHI BAXA CORP. 724 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1