Description of Event or Problem · 1
AGFA SUBMITTED TO THE FDA ON OCTOBER 25, 2012 A MDR REPORT # 1225058-2012-00016 FOR ANOTHER SITE WITH THE SAME ISSUE AS REPORTED IN THIS SUBMISSION. THE PRODUCT ISSUE IS THE BASELINE PULMONARY CAPILLARY WEDGE (PCW) PRESSURE VALUES FROM IMPAX CV REPORTING CARDIAC CATHETERIZATION MODULE WERE NOT CORRECTLY TRANSFERRING INTO THE HOSPITAL¿S ELECTRONIC HEALTH RECORD (EHR) SYSTEM. WITHIN THE EHR, RIGHT ATRIAL (RA) PRESSURE VALUES ARE SUBSTITUTED FOR THE BASELINE PCW PRESSURE VALUES WHENEVER THESE VALUES APPEARED AS PART OF A PATIENT REPORT. A REPORTABLE CORRECTION IS CURRENTLY UNDERWAY FOR THIS ISSUE WHICH WAS REPORTED TO THE FDA ON MARCH 15, 2013. THE FDA REFERENCE # IS Z-1070-13. DURING THE IMPLEMENTATION OF THIS RECALL ACTIVITY, AN AGFA PROFESSIONAL SERVICES PERSON WAS AT (B)(6) HOSPITAL AND RECORDED THE RECALL ACTIVITIES AND OBSERVATIONS FOR THIS SITE. ON MAY 23, 2013, AGFA REVIEWED THE STATUS OF THE RECALL ACTIVITIES FOR THE SITES THAT HAD BEEN CHECKED SINCE THE INITIATION OF THE REPORTABLE CORRECTION, AND DETERMINED THAT MULTIPLE MDRS NEEDED TO BE REPORTED FOR (B)(6) HOSPITAL. MAY 23, 2013 IS BEING USED AS THE AWARENESS DATE UPON REVIEW OF THE RECALL ACTIVITIES. DURING THE INVESTIGATION IT WAS DISCOVERED 595 STUDY DATES WERE IMPACTED AND INCLUDED 898 STUDY IDS. AGFA WILL SUBMIT A MDR TO THE FDA FOR EACH OF THE 595 STUDY DATES AND INCLUDE THE SPECIFIC STUDY IDS REFERENCING EACH STUDY DATE. THIS CUSTOMER NOW HAS THE LATEST MAPPING CHANGES IN THEIR TEST ENVIRONMENT AND AGFA IS WORKING WITH THE CUSTOMER TO MOVE THE CHANGES TO PRODUCTION, OBTAIN FINAL SIGN OFF AND APPROVAL FOR THE CHANGES. FINAL CORRECTIVE ACTIONS FOR THIS SITE WILL BE DOCUMENTED IN THE REPORTABLE CORRECTION: FDA REFERENCE # Z-1070-13. THERE IS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. THE 595 MDR SUBMISSION NAMES FOR THE ENTIRE EVENT WILL INCLUDE: 1225058-2013-00206 THROUGH 1225058-2013-00800. THIS MDR INCLUDES: (B)(4).