BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 8484750 · Received April 4, 2019

    Report

    Report Number
    1628664-2019-00289
    Event Type
    Injury
    Date Received
    April 4, 2019
    Report Date
    April 24, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A REVIEW OF THE ISSUE, IT WAS NOTED THAT THE CUSTOMER WAS NOT USING APPROPRIATE PPE WHILE PERFORMING MAINTENANCE/ TROUBLESHOOTING ON THE ARCHITECT C8000 ANALYZER. ABBOTT FIELD SERVICE (FS) DETERMINED THE CAUSE TO BE BACK PRESSURE FROM A CLOGGED WASTE PUMP QUICK CONNECT , FITTING KIT, WASTE PUMP QUICK CONNECT (ROHS)) ON THE EXTERNAL WASTE PUMP. THE ISSUE WAS RESOLVED BY CLEANING THE CLOGGED CONNECTOR AND PERFORMING A TOTAL CALL PROCEDURE. A REVIEW OF THE ARCHITECT C802080 SERVICE HISTORY FOUND NO ADDITIONAL LIKELY CAUSES AND NO FURTHER SIMILAR ISSUES HAVE BEEN REPORTED. A REVIEW OF TICKETS FOR THE WASTE PUMP QUICK CONNECT DID NOT IDENTIFY ANY ISSUES OR ADVERSE TRENDS. NO OTHER SIMILAR COMPLAINTS WERE FOUND INVOLVING A SPLASH EXPOSURE. A REVIEW OF TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS REVEALED NO SYSTEMIC ISSUES OR ADVERSE TRENDS RELATED TO THE ISSUE IN THIS COMPLAINT. MANUFACTURING DOCUMENTATION AND LABELING WAS REVIEWED AND NOTED TO PROVIDE SUFFICIENT INFORMATION REGARDING OPERATIONAL PRECAUTIONS AND LIMITATIONS, OPERATOR RESPONSIBILITY, HAZARDS AND EXPOSURE TO POTENTIALLY INFECTIOUS OR HAZARDOUS MATERIAL, USING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE), PERFORMING MAINTENANCE, AND TROUBLESHOOTING THE REPORTED ISSUE TO INCLUDE REPLACING / CLEANING THE EXTERNAL WASTE PUMP, TUBING, AND CONNECTORS. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY OR SYSTEMIC ISSUES WERE IDENTIFIED FOR THE WASTE PUMP QUICK CONNECT OR THE ARCHITECT C8000 ANALYZER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE USER WAS INSPECTING THE INSTRUMENT AFTER NOTICING LEAKAGE AT THE FRONT. THE USER SAW THAT THE LEAKING WAS COMING FROM THE T FOR THE HIGH CONCENTRATION WASTE AND ICT WASTE. SHE INSPECTED THE BACK OF THE INSTRUMENT AND WHEN SHE RETURNED TO THE FRONT, THE USER WAS SPLASHED IN THE FACE WHEN THE ICT TUBING OF THE ARCHITECT C8000 ANALYZER SPRAYED DUE TO BLOCKAGE OF THE EXTERNAL HC WASTE TUBING. THE OPERATOR WAS A (B)(6) FEMALE, RECEIVED MEDICAL TREATMENT AND WAS GIVEN AN ANTI-VIRAL PRESCRIPTION. SHE ALSO HAD A SWAB TEST IN THE MOUTH PERFORMED BECAUSE OF THE LIQUID CONTACT WITH HER MOUTH AND THE RESULTS ARE AS FOLLOWS: THROAT SWAB CULTURE NEGATIVE, (B)(6), HERPES 2 IGG AND IGM PENDING, VIRAL LOAD PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275782 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention