BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFETRACE TX, REBRANDED AS HORIZON BLOOD BANK

    MDR report key: 1416630 · Received April 23, 2009

    Report

    Report Number
    2951268-2009-00002
    Event Type
    Other
    Date Received
    April 23, 2009
    Date of Event
    March 23, 2009
    Report Date
    April 23, 2009
    Manufacturer
    WYNDGATE TECHNOLOGIES
    Product Code
    MMH
    PMA / PMN Number
    BK980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE MEDICAL DEVICE PERFORMED AS INTENDED AND DID NOT MALFUNCTION. THE REPORTED INCIDENT OCCURRED SOLELY BECAUSE OF A UNIQUE SET OF SEQUENTIAL OPERATOR ERRORS. THIS SCENARIO IS UNIQUE BECAUSE THE OPERATOR ENTERED THE SAME ERRONEOUS SPECIMEN NUMBER ON TWO CRITICAL WINDOWS; ON THE RESULT ENTRY WINDOW, IF THE OPERATOR HAD ENTERED ANY SPECIMEN NUMBER OTHER THAN THE SAME ONE THAT WAS INCORRECTLY LINKED PREVIOUSLY, THE MEDICAL DEVICE WOULD HAVE DETECTED THE OPERATOR ERROR. WYNDGATE RECOMMENDS THAT THE SITE RETRAIN ITS EMPLOYEES ON THE PROPER USE OF WYNDGATE'S SOFTWARE. IT SHOULD ALSO IMPLEMENT ADDITIONAL OPERATOR CONTROLS ON ITS PROCESS LINKING THE SPECIMEN TO THE PATIENT. THE MEDICAL DEVICE IS DEPENDENT ON THE OPERATOR CONSISTENTLY AND ACCURATELY ENTERING CORRECT DATA FOR THE PROPER FUNCTIONING OF THIS SYSTEM. THE SOFTWARE CAN ONLY REACT TO THE DATA THAT IS ENTERED. IN THIS CASE, WHERE THE WRONG DATA WAS ENTERED TWICE, HHB HAD NO WAY TO CONTROL THE OUTCOME. THE LINKAGE OF THE SPECIMEN TO THE PATIENT IS A CRITICAL ENTRY POINT WHICH FURTHER DEVICE PROCESSING OCCURS. A REMINDER WILL BE SENT TO ALL CLIENTS TO REITERATE THE IMPORTANCE OF PROPER SPECIMEN LINKAGE AND DATA ENTRY. ACTION TAKEN - AS A PRECAUTION, WYNDGATE SENT A PRODUCT BULLETIN TO ALL OF ITS CLIENTS USING THE HBB SYSTEM REITERATING THE IMPORTANCE OF PROPER SPECIMEN LINKAGE AND DATA ENTRY. THIS SAME NOTICE WILL ALSO EMPHASIZE THE NEED TO THOROUGHLY TRAIN EMPLOYEES ON THE PROPER USE OF THE HBB SYSTEM.

    Description of Event or Problem · 1

    A CLIENT SITE REPORTED AN EVENT ON (B)(6) 2009 WHICH WAS CAUSED BY A SEQUENCE OF OPERATOR ERRORS. THE MEDICAL DEVICE WYNDGATE'S SAFETRACE TX REBRANDED AS HORIZON BLOOD BANK DID NOT MALFUNCTION. THE SCENARIO AT THE REPORTING SITE INVOLVED TWO PATIENTS (PATIENT A AND PATIENT B FOR DESCRIPTIVE REASONS) AND THEIR ASSOCIATED BLOOD SPECIMENS. AS A CONSEQUENCE OF SEQUENTIAL USER ERRORS IN ENTERING THE PATIENT'S SPECIMEN ACCESSION NUMBER, THE TESTING RESULTS FROM AN INCORRECTLY IDENTIFIED SPECIMEN WERE LINKED TO THE WRONG PATIENT. INFORMATIONAL BULLETINS HAVE BEEN DISTRIBUTED BY WYNDGATE TO ALL SITES THAT CURRENTLY USING EITHER HORIZON BLOOD BANK OR SAFETRACE TX PRODUCTS. ADDITIONAL MANUFACTURER NARRATIVE IS INCLUDED WITH THIS REPORT AS AN ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETRACE TX, REBRANDED AS HORIZON BLOOD BANK STANDALONE BLOOD BANK SOFTWARE MMH WYNDGATE TECHNOLOGIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1