BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VP 2000 PROCESSOR

    MDR report key: 2370307 · Received May 20, 2011

    Report

    Report Number
    3005248192-2011-00008
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KEY
    Removal / Correction Number
    Z-2313-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR INC. IS AWARE OF THE PROBLEM WITH THE VP 2000 PROCESSOR BASINS. AN URGENT PRODUCT RECALL (Z-2313-2010) WAS DISTRIBUTED VIA FEDEX SHIPMENT TO UNITED STATES CUSTOMERS BASED ON CUSTOMER RECEIPT OF VP 2000 PROCESSOR AND BASIN SPARE PART SINCE SEPTEMBER 2008. THE RECALL WAS CONCLUDED IN THE UNITED STATES IN OCTOBER, 2010; ALL LEAKING BASINS WERE REPLACED AND ALL NON-LEAKING BASINS WERE INSPECTED BY ABBOTT FIELD SERVICE PERSONNEL. BASED ON AN ADDITIONAL COMPLAINT (SEE MDR 3005248192-2010-00012 FOR MORE INFORMATION) ANOTHER URGENT PRODUCT RECALL WAS ISSUED FA CAM-DEC2010-093. THIS RECALL WILL COORDINATE REPLACEMENT OF ALL VP 2000 HEATER BASINS IMPACTED BY THIS MANUFACTURING ISSUE. THE RECALL # Z-2313-2010 WAS AMENDED TO INCLUDE THESE ADDITIONAL REPLACEMENTS. THE FOLLOWING MDRS WERE ALSO FILED: (B)(4). THREE POTENTIAL HAZARDS WERE IDENTIFIED: DELAY IN RESULTS. THERE IS NO HARM ASSOCIATED WITH THIS HAZARD. CHEMICAL EXPOSURE. THERE IS NO HARM ASSOCIATED WITH THIS HAZARD AS THIS ISSUE DOES NOT INCREASE THE ALREADY EXPECTED EXPOSURE TO THESE REAGENTS. THEREFORE, THERE IS NO INTRODUCED OPERATOR HARM. SLIP HAZARD. EVALUATION DETERMINED THAT THE OVERALL HEALTH RISK WAS LOW, BASED ON THE FOLLOWING: THE POST CORRECTION LEAKING BASING WAS 0.4%. LEAKING RATE IS EXPECTED TO BE ABOUT ONE TO TWO DROPS PER MINUTE < 100 UL PER MIN.) WHEN A LOADED BASIN IS EITHER USED IN THE VP2000 OR STORED ON THE LAB BENCH, IN THE TYPICAL USAGE TIME < 8 HOURS), THE LEAKED LIQUID WOULD BE LESS THAN 50 ML. SLIP HAZARD WOULD BE AVOIDED BY THE OPERATOR'S OBSERVANCE OF THE LIQUID ON THE FLOOR AND BY THE SMALL VOLUME OF LIQUID. IF A LEAK WERE TO OCCUR, IT WOULD OCCUR IN AN AREA THAT A LAB OPERATOR WOULD NOT NORMALLY WALK (IN THE VP2000) OR DURING REAGENT ADDITION (LAB BENCH). IN ADDITION, THE LEAK WOULD BE VISUALLY OBVIOUS TO THE OPERATOR. IF THE OPERATOR DID STEP ON THE LEAK, IT WOULD NOT NECESSARILY LEAD TO A FALL THAT WOULD LEAD TO A SERIOUS INJURY.

    Description of Event or Problem · 1

    THE ABBOTT VP 2000 PROCESSOR IS A DEVICE DESIGNED TO AUTOMATE AND STANDARDIZE SLIDE SPECIMEN PROCESSING AND ROUTINE SLIDE STAINING FOR THE LABORATORY. CUSTOMER REPORTED HAVING A LEAKING BASIN. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VP 2000 PROCESSOR STAINER, TISSUE, AUTOMATED, PRODUCT CODE: KEY KEY ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1