BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA-MIX 2400, MAIN MODULE

    MDR report key: 1812853 · Received June 11, 2010

    Report

    Report Number
    1419106-2009-00014
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Report Date
    May 15, 2009
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO BAXA AND EVALUATED. A VISUAL INSPECTION OF THE DEVICE REVEALED A BROKEN OFF VALVE ACTUATOR BUTTON ON PORT 8. THIS IS A KNOWN ISSUE AT BAXA FROM WHICH CORRECTIVE ACTIONS HAVE BEEN INITIATED. AN EXTENSIVE FAILURE ANALYSIS INVESTIGATION WAS CONDUCTED TO DETERMINE ROOT CAUSE OF THE DAMAGED VALVE ACTUATOR. THIS FAILURE ANALYSIS INVESTIGATION INCLUDED TWO TYPES OF TESTING. THE FIRST TYPE OF TESTING WAS PHYSICAL TESTING THAT INCLUDED FATIGUE TESTING, IMPACT TESTING, TORQUE TESTING AND ANALYSIS OF A SECTIONAL VIEW OF THE VALVE ACTUATOR. (THIS INCLUDED USING AN OUTSIDE SOURCE TO ASSIST IN THE FAILURE ANALYSIS INVESTIGATION). THE SECOND TYPE WAS SIMULATED CUSTOMER USE TESTING, WHICH INCLUDED CUSTOMER SITE VISITS. RESULTS OF EVALUATION: BASED UPON THE RESULTS OF THE INVESTIGATION, THE MOST LIKELY CAUSE OF FAILURE OF THE VALVE ACTUATOR IS AN IMPACT BREAK AND NOT A FATIGUE BREAK. THIS BREAK IS MOST LIKELY CAUSED BY ITEMS ACCIDENTALLY DROPPED ONTO THE VALVE ACTUATORS. ALL CUSTOMERS WERE NOTIFIED ON (B)(4) 2008 BY A SAFETY ALERT LETTER ((B)(4)) OUTLINING THE BROKEN VALVE ACTUATOR ISSUE. CUSTOMERS WERE NOTIFIED IN THE SAFETY ALERT TO 'DO NOT USE THE MAIN MODULE IF ANY OF THE 24 VALVE ACTUATORS ARE DAMAGED'. THE EM2400 TECHNICAL MANUAL WAS UPDATED TO VISUALLY INSPECT ALL VALVE ACTUATORS BEFORE SETUP AND AFTER TEAR-DOWN TO ENSURE THEY ARE NOT DAMAGED OR BENT AND TO NOT USE THE MAIN MODULE 2400-M(R) IF THE VALVE ACTUATORS ARE DAMAGED OR BENT. A STICKER WAS ADDED TO THE 2400-M(R) THAT INSTRUCTS THE USER TO VISUALLY INSPECT ALL VALVE ACTUATORS AND TO NOT USE IF THE VALVE ACTUATORS ARE DAMAGED OR BENT. THE SUBJECT DEVICE RETURNED TO BAXA DID NOT HAVE THE STICKER APPLIED. (B)(6) CONFIRMED WITH BAXA ON (B)(6) 2009 THAT THEIR CURRENT DEVICES DO HAVE THE STICKER APPLIED. THE BREAK IS AN IMPACT BREAK MOST LIKELY CAUSED BY AN ACCIDENTAL DROP ON THE VALVE ACTUATORS.

    Description of Event or Problem · 1

    THE MAUDE DATABASE WAS REVIEWED BY BAXA CORPORATION'S QUALITY DEPARTMENT ON (B)(4) 2009. MEDWATCH (B)(4) WAS DISCOVERED IN REGARDS TO A BROKEN VALVE ACTUATOR ON THE EXACTA-MIX 2400 COMPOUNDER. BAXA'S CUSTOMER COMPLAINT SYSTEM WAS REVIEWED AND THE ASSOCIATED COMPLAINT WAS IDENTIFIED. THE CUSTOMER CONTACTED BAXA TECHNICAL SUPPORT ON (B)(6) 2009 ABOUT A BROKEN VALVE ACTUATOR AT PORT 8. DURING THIS INITIAL CONTACT, THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO OPERATOR INJURY. THE CUSTOMER DID NOT INDICATE THAT THEY INTENDED TO SUBMIT A MEDWATCH AT THE TIME THE COMPLAINT WAS REPORTED. THE PRODUCT WAS RETURNED FOR EVALUATION. THIS MDR IS BEING FILED PER BAXA CORPORATION'S PROCEDURE TO SUBMIT AN MDR FOR ALL MEDWATCH FORMS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400, MAIN MODULE EXACTA-MIX 2400, MAIN MODULE LHI BAXA CORPORATION 2400-MR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA