BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT COMMANDER PPC

    MDR report key: 918696 · Received September 26, 2007

    Report

    Report Number
    1628664-2007-00433
    Event Type
    Injury
    Date Received
    September 26, 2007
    Date of Event
    August 27, 2007
    Report Date
    August 27, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    K897158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT TEXT INDICATES AN ABBOTT FIELD SERVICE REP (FSR) WITNESSED A COMMANDER PPC OPERATOR ATTEMPTING TO CHANGE THE WASTE TUBING ON THE PPC. THE PPC WAS POWERED UP, PRESSURIZED AND PERFORMING A WASH. THE OPERATOR PULLED OFF THE WASTE LINE, AND SINCE THE INSTRUMENT WAS IN THE PROCESS OF WASHING, THE WASTE LINE SPRAYED WASTE IN THE CUSTOMER'S EYES. THE OPERATOR WAS NOT WEARING SAFETY GOGGLES. THE OPERATOR WAS NOT FOLLOWING THE OPERATIONS MANUAL INSTRUCTIONS ON HOW TO CHANGE THE WASTE, WATER AND AIR TUBING. THE OPERATOR DID REPORT TO OCCUPATIONAL HEALTH FOR AN EXPOSURE WORKUP. THERE HAS BEEN NO ADDITIONAL INFORMATION DOCUMENTED. THE FSR REQUESTED THE OPERATOR TO NOTIFY ABBOTT OF THE INCIDENT, AND THAT HE WOULD NEED TO ALSO REPORT THE INCIDENT. SERVICE HISTORY REVIEW OF COMMANDER PPC INDICATES THERE ARE NO SIMILAR OR POTENTIAL INJURY COMPLAINTS OVER THE TIME PERIOD OF 2006 THROUGH 2007. DEVICE HISTORY RECORD (DHR) INDICATES COMMANDER PPC PASSED ALL MANUFACTURING REQUIREMENTS AND WAS RELEASED FOR DISTRIBUTION ON 06/15/1988. CONCLUSION: THE MOST PROBABLE CAUSE FOR THE WATER SPLASHING IN THE FACE, IS THE OPERATOR DID NOT FOLLOW SAFETY WARNINGS AS DIRECTED BY THE OPERATIONS MANUAL. THE OPERATOR WAS NOT WEARING SAFETY GOGGLES, AND ATTEMPTED TO CHANGE THE WASTE TUBING WHILE THE ANALYZER WAS IN OPERATION. THERE IS SUFFICIENT LABELING IN THE COMMANDER PPC OPERATIONS MANUAL TO PREVENT POTENTIAL INJURY. LABELING: PPC SYSTEM OPERATION MANUAL (LN# 1A05-57) SECTION 7, OPERATIONAL PRECAUTIONS, AND LIMITATIONS WARNS OF POTENTIAL BIOHAZARD, AND THE CONNECTORS ON THE WASTE LINE MUST BE FULLY ENGAGED TO AVOID SPLASHING, LEAKAGE OR BACKUP OF WASTE THROUGH THE SYSTEM. SECTION 5, OPERATING INSTRUCTIONS, PRE-OPERATING PROCEDURES, CHECK THE TUBING, INSTRUCTS THE OPERATOR TO VERIFY ALL TUBING IS PROPERLY CONNECTED TO BOTH THE CART, AND THE INSTRUMENT, AND TO CHECK FOR LEAKS, CRACKS AND DISCOLORATION. THE POWER SHOULD BE TURNED OFF, AND THE UNIT UNPLUGGED BEFORE WORKING INSIDE THE INSTRUMENT. AN EMERGENCY STOP PROCEDURE IS PROVIDED. SECTION 8, HAZARDS, WARNS OF POTENTIAL BIOHAZARD THAT MIGHT BE ENCOUNTERED WHILE OPERATING THE PPC. BIOLOGICAL HAZARDS: CONSIDER ALL SPECIMENS, CONTROLS, CALIBRATORS, SURFACES, WASTE OR COMPONENTS AS POTENTIALLY INFECTIOUS. WEAR GLOVES, A LAB COAT, AND PROTECTIVE EYEWEAR WHEN OPERATING OR MAINTAINING THE PPC. OBSERVE OTHER BIOSAFETY PRACTICES AS SPECIFIED IN THE OSHA BLOODBORNE PATHOGEN RULE (29 CFR PART 1910.1030) OR OTHER EQUIVALENT BIOSAFETY PROCEDURES. DECONTAMINATION PROCEDURE STATES THE INSTRUMENT SHOULD BE DECONTAMINATED PRIOR TO SERVICING, SHIPMENT OR MOVEMENT. SECTION 9, SERVICE AND MAINTENANCE, WASH SYSTEM MAINTENANCE, TUBING AND CONNECTIONS INSTRUCTS THE OPERATOR TO CHECK TUBING, AND ITS CONNECTING ENDS DAILY FOR LEAKS, CRACKS AND DISCOLORATION, AND TO REPLACE IF PARTS ARE DAMAGED OR DETERIORATED. TO REPLACE THE EXTERNAL TUBING, THE ANALYZER MUST BE TURNED OFF AND THE AIR PRESSURE RELEASED IN THE WATER CANISTER. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    WHILE VISITING A CUSTOMER ACCOUNT AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WITNESSED AN INJURY. THE CUSTOMER WAS TRYING TO CHANGE THE WASTE TUBING ON THE COMMANDER PPC WHILE THE INSTRUMENT WAS POWERED UP, PRESSURIZED AND PERFORMING A WASH. THE CUSTOMER PULLED OFF THE WASTE LINE, AND SINCE THE INSTRUMENT WAS IN THE PROCESS OF WASHING, WASTE WAS SPRAYED IN THE CUSTOMER'S EYE. THE CUSTOMER WAS NOT WEARING SAFETY GOGGLES. THE CUSTOMER WENT TO THEIR OCCUPATIONAL HEALTH DEPARTMENT FOR A POST EXPOSURE WORK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER PPC AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS JQW ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other