BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV REPORTING

    MDR report key: 2844645 · Received November 12, 2012

    Report

    Report Number
    1225058-2012-00052
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 12, 2012
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PROBLEM IS THE BASELINE PULMONARY CAPILLARY WEDGE (PCW) PRESSURE VALUES FROM AGFA'S IMPAX CV REPORTING CARDIAC CATHETERIZATION MODULE WERE NOT CORRECTLY TRANSFERRING INTO THE HOSPITAL'S (EHR) SYSTEM. WITHIN THE EHR, RIGHT ATRIAL (RA) PRESSURE VALUES ARE SUBSTITUTED FOR THE BASELINE PCW PRESSURE VALUES. AGFA'S INVESTIGATION DETERMINED THE BASELINE PCW PRESSURE VALUES DISPLAYED CORRECTLY WITHIN THE IMPAX CV REPORTING CARDIAC CATHETERIZATION REPORT ITSELF AND THAT TWO VALUES IN THE STANDARD IMPAX CV OUTBOUND REPORTING STYLE SHEETS FOR THE CARDIAC CATHETERIZATION MODULE ARE INCORRECTLY MAPPING TO THE RIGHT ATRIAL (RA) PRESSURE FIELD. THE TWO VALUES ARE PULMONARY CAPILLARY WEDGE (PCW) AND LEFT ATRIAL (LA) PRESSURE. THESE ARE CURRENTLY MAPPING TO THE RIGHT ATRIAL (RA) FIELD IN THE IMPAX CV OUTBOUND REPORTING STYLESHEETS. THIS WILL RESULT IN RIGHT ATRIAL (RA) MEASUREMENT VALUES INCORRECTLY POPULATING IN THE PULMONARY CAPILLARY WEDGE (PCW) AND LEFT ATRIAL (LA) FIELDS IN A CUSTOMER'S ELECTRONIC HEALTH SYSTEM (EHR). ON (B)(4) 2012, AGFA CORRECTED THE PCW PRESSURE ISSUE ON THE SITE'S TEST SYSTEM AND IS AWAITING THE SITE'S CONFIRMATION THE CHANGES MADE TO THE TEST SYSTEM ARE WORKING CORRECTLY AND ALL OF THE REPORTS ARE REPROCESSED CORRECTLY. ONCE CONFIRMED, THE CHANGES WILL BE MADE TO THE SITE'S PRODUCTION SYSTEM. AGFA HEALTHCARE WILL BE IMPLEMENTING A REPORTABLE CORRECTION TO THE FDA FOR THIS ISSUE WHICH WILL BE APPLIED AT AFFECTED CONSIGNEE SITES. ADDITIONALLY, AGFA HEALTHCARE WILL WORK WITH ALL AFFECTED CONSIGNEES TO IDENTIFY ALL IMPACTED REPORTS AND WILL ASSIST IN THE REPROCESSING OF THIS REPORTS.

    Description of Event or Problem · 1

    ON OCTOBER 25, 2012, AGFA SUBMITTED MDR 1225058-2012-00016 FOR THE SAME PROBLEM AND THE SAME CUSTOMER AS THE MDR SUBMISSION. AGFA BECAME AWARE OF ADD'L REPORTS ON (B)(4) 2012. THE CUSTOMER PROVIDED MEDICAL RECORDS NUMBERS FOR THE ADD'L REPORTS AND BASED ON GUIDANCE FROM THE FDA MDR POLICY BRANCH ON 11/2/2012, AGFA IS SUBMITTING INDIVIDUAL 3500A FORMS FOR THESE REPORTS. THE PT MEDICAL RECORD NUMBER (MRN) FOR THIS MDR REPORT IS MRN# (B)(6). THE CUSTOMER IS UNABLE TO PROVIDE AN EXACT DATE FOR THIS REPORT. THEREFORE, THE DATE RANGE WHEN THE MRN WAS TRANSFERRED TO THE CUSTOMER'S ELECTRONIC HEALTH RECORD (EHR) IS BETWEEN MAY 2011 AND NOVEMBER 2, 2012. THERE HAVE BEEN NO REPORTS OF PT HARM ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV REPORTING IMPAX CV OUTBOUND REPORT LLZ AGFA HEALTHCARE CORP. GREATER THAN OR EQUAL TO CV 7.8

    Patients

    Seq Age Sex Outcome Treatment
    1