BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV REPORTING

    MDR report key: 3220759 · Received July 8, 2013

    Report

    Report Number
    1225058-2013-00815
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 8, 2013
    Manufacturer
    AGFA HEALTHCARE CORPORATION
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Removal / Correction Number
    Z-1070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PROBLEM AT THAT TIME WAS 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 AT THAT TIME, 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 WERE INCORRECTLY MAPPING TO THE RIGHT ATRIAL (RA) PRESSURE FIELD. THE TWO VALUES ARE PULMONARY CAPILLARY WEDGE (PCW) AND LEFT ATRIAL (LA) PRESSURE. THESE VALUES WERE MAPPING TO THE RIGHT ATRIAL (RA) FIELD IN THE IMPAX CV OUTBOUND REPORTING STYLESHEETS. THIS RESULTED 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). THESE PREVIOUSLY AFFECTED REPORTS HAVE ALL BEEN CORRECTED BY AGFA. DURING THE INVESTIGATION, IT WAS DETERMINED 132 STUDY DATES WERE IMPACTED AND INCLUDED THE 140 REPORTS. AGFA WILL SUBMIT AN MDR TO THE FDA FOR EACH OF THE 132 STUDY DATES AND INCLUDE THE RESPECTIVE MRNS REFERENCED ON EACH STUDY DATE. DOCUMENTATION OF ANY CORRECTIONS REQUIRED FOR THIS EVENT WILL BE REPORTED VIA FDA REFERENCE # Z-1070-2013. (B)(4). THE FOLLOWING IS THE STUDY DATE AND MRNS FOR THIS MDR. 1225058-2013-00815 (B)(4).

    Description of Event or Problem · 1

    ON JUNE 14, 2013, AGFA'S TECHNICAL PROJECT MANAGER WAS PERFORMING A HOTFIX DEPLOYMENT FOR THIS CUSTOMER SITE, RELATED TO CORRECTIONS AGFA REPORTED ON MARCH 15, 2013 TO THE FDA. (FDA REFERENCE# Z-1070-2013). IN 2012, AGFA REPORTED THIS SAME CUSTOMER AND ISSUE FOR PREVIOUSLY IDENTIFIED STUDY DATES AND THEIR RESPECTIVE REPORTS WHICH ARE DOCUMENTED IN MDRS 1225058-2012-00016 THROUGH 1225058-2012-00067. THESE PREVIOUSLY AFFECTED REPORTS HAVE ALL BEEN CORRECTED BY AGFA. THE HOTFIX BEING APPLIED TO SITES WAS RELEASED APRIL 2013 FOR USE IN THE CORRECTION DESCRIBED IN FDA Z-1070-2013. THE HOTFIX CONSISTS OF 2 PARTS: PART 1: IDENTIFY POTENTIALLY AFFECTED REPORTS BASED BY IDENTIFYING IF PCW PRESSURE, LA PRESSURE AND RA PRESSURE VALUES WERE PRESENTED IN THE IMPAX CV REPORTING CARDIAC CATHETERIZATION REPORT. THESE REPORTS ARE POTENTIALLY AT RISK TO BE INCORRECT ONCE EXPORTED TO THE HOSPITAL'S EHR. PART 2: THE CUSTOMERS WILL HAVE THE OPPORTUNITY TO RE-SIGN AND REPROCESS IDENTIFIED AFFECTED REPORTS INTO THEIR EHR SYSTEMS TO FULLY APPLY THE CORRECTION TO THE PRIOR REPORTS. DEPENDING ON THE CUSTOMER'S RESPONSE, THOSE REPORTS ARE RE-RENDERED TO CORRECT ANY POTENTIAL INCORRECT MISMAPPING. DURING THE DEPLOYMENT OF THE HOTFIX (PART 1) AT THIS CUSTOMER SITE, AGFA IDENTIFIED 140 POTENTIALLY AFFECTED REPORTS, AS THESE REPORTS CONTAIN LA PRESSURE; RA PRESSURE AND PCW PRESSURE VALUES. THESE REPORTS WERE NOT IDENTIFIED BY AGFA NOR THE CUSTOMER, IN THE PREVIOUS REPORTED MDRS AND WILL REQUIRE VERIFICATION BY THE CUSTOMER. THE CUSTOMER WILL BE NOTIFIED, AND A LIST OF ALL AFFECTED REPORTS WILL BE PROVIDED TO THE CUSTOMER FOR VERIFICATION AGAINST THEIR EHR. AGFA WILL ASSIST THE CUSTOMER IN RE-RENDERING THOSE REPORTS, AS NECESSARY. THERE HAVE BEEN NO REPORTS OF PT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310317 IMPAX CV REPORTING IMPAX CV OUTBOUND REPORT LLZ AGFA HEALTHCARE CORPORATION GREATER THAN OR EQUAL TO CV 7.8

    Patients

    Seq Age Sex Outcome Treatment
    1