BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM 6 CHANNEL ANALYZER

    MDR report key: 2771022 · Received October 3, 2012

    Report

    Report Number
    1628664-2012-00444
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K970042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CUSTOMER CONTACTED ABBOTT TO REPORT THAT THE AIR TIP WASH COMPRESSOR FAILED TO TURN ON (ERROR CODE 3X-700). THE FSE CALLED THE CUSTOMER AND ASKED HIM TO BLOW COMPRESSED AIR OVER THE AIR COMPRESSOR PUMPS TO CLEAR ANY DUST FROM THE PUMPS. CUSTOMER PERFORMED AS INSTRUCTED, BUT FAILED TO TURN THE POWER OFF WHEN DOING SO AND WHEN AIR WAS BLOWN ON THE PUMPS IT PRODUCED A FLAME. THE CUSTOMER WAS ABLE TO POWER OFF THE INSTRUMENT AND PREVENT A FIRE. AFTER POWERING BACK ON, ALL AIR COMPRESSOR PUMPS WERE TESTED USING DIAGNOSTICS, AND ONLY THE CHANNEL 1 PUMP WAS NOT RESPONDING. THE FSE REPLACED THE PART TO RESOLVE THE ISSUE. REVIEW OF THE ABBOTT PRISM SYSTEM RISK MANAGEMENT REPORT AND ABBOTT PRISM OPERATIONS MANUAL DETERMINED HAZARDS HAVE BEEN SUFFICIENTLY ADDRESSED WITH RESPECT TO THIS EVENT. REVIEW OF THE ABBOTT PRISM SYSTEM SERVICE AND SUPPORT MANUAL DETERMINED THAT ADEQUATE INSTRUCTIONS ARE INCLUDED FOR TROUBLESHOOTING AIR TIP WASH ERRORS AND FOR REPLACING THE AIR TIP WASH COMPRESSOR AND PERFORMING OPERATIONAL VERIFICATION. THE FIRST STEP OF THE REMOVAL AND REPLACEMENT PROCEDURE IS TO POWER OFF THE PRISM INSTRUMENT. THE PROCEDURES DO NOT INSTRUCT ON THE USE OF COMPRESSED AIR PRODUCTS. REVIEW OF FSE ACTIONS HAS DETERMINED THAT THIS COMPLAINT ISSUE OCCURRED DUE TO HUMAN ERROR. THE FSE INDICATED HE KNEW THE PRISM INSTRUMENT NEEDED TO BE POWERED OFF BEFORE PERFORMING TROUBLESHOOTING; HOWEVER, THE CUSTOMER HAD BLOWN THE COMPRESSED AIR ACROSS THE COMPRESSORS BEFORE HE HAD A CHANCE TO INSTRUCT HIM TO POWER IT OFF. THIS INVESTIGATION HAS DETERMINED THAT IN THE PRESENCE OF ADEQUATE LABELING, THE FSE INSTRUCTED THE CUSTOMER INCORRECTLY. SPECIFICALLY, THE FSE FAILED TO ENSURE THE PRISM WAS POWERED OFF BEFORE BEGINNING TROUBLESHOOTING AND ADVISED ON USE OF COMPRESSED AIR WHICH IS NOT PART OF THE ABBOTT PRISM SYSTEM SERVICE AND SUPPORT MANUAL PROCEDURES. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE CUSTOMER ISSUE OF FLAME OBSERVED ON THE COMPRESSOR. THE FLAME WAS A RESULT OF HUMAN ERROR DUE TO INCORRECT INSTRUCTIONS PROVIDED BY THE ABBOTT FSE. A NONCONFORMANCE HAS BEEN OPENED TO CONDUCT AN HEID (HUMAN ERROR INVESTIGATION AND DIAGNOSTICS) AND TO IDENTIFY POTENTIAL ACTIONS TO ADDRESS THIS ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION/PRODUCT DEFICIENCY WITH THE PRISM ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER WAS PERFORMING TROUBLESHOOTING ON THE PRISM ANALYZER. THE FIELD SERVICE ENGINEER (FSE) INSTRUCTED THE CUSTOMER TO BLOW COMPRESSED AIR OVER THE AIR COMPRESSOR PUMPS TO CLEAR ANY DUST FROM THE PUMPS. THE CUSTOMER PERFORMED AS INSTRUCTED, BUT FAILED TO TURN THE POWER OFF WHEN DOING SO AND WHEN AIR WAS BLOWN ON THE PUMPS IT PRODUCED A FLAME. CUSTOMER WAS ABLE TO POWER OFF THE ANALYZER AND PREVENT FIRE. THE CUSTOMER ALSO STATED THAT THE TOP OF THE COMPRESSOR PUMP, CHANNEL 1 WAS VERY HOT TO THE TOUCH. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM 6 CHANNEL ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1