DONOR INFORMATION SYSTEM (DIS)

Description of Event or Problem

THE DONOR INFORMATION SYSTEM (DIS) DONOR SCREENING MODULE CONNECTS WITH CDCS TO VERIFY WHETHER A DONOR HAS DONATED AT ANOTHER PLASMA DONATION FACILITY BY CHECKING THE DONOR'S NAME, GENDER, DATE OF BIRTH, AND DONOR ID. EXACT MATCHES ARE AUTOMATICALLY DEFERRED OR MARKED AS INTERNAL BIOLIFE DONATIONS, WHILE PARTIAL MATCHES TRIGGER A "CDCS POSSIBLE MATCH FOUND" SCREEN REQUIRING THE USER TO SELECT "MATCH DEFER DONOR" OR "NOT A MATCH," WITH THE DECISION SAVED IN THE DIS DATABASE. AN ISSUE IN DIS DONOR SCREENING VERSION 8.0.0.41 ALLOWED A USER TO DISMISS THE "CDCS POSSIBLE MATCH FOUND" SCREEN USING THE ESC KEY, BYPASSING THE WORKFLOW AND PREVENTING THE MATCH DECISION FROM BEING SAVED IN THE DIS DATABASE. NO KNOWN ADVERSE EVENTS HAVE BEEN ASSOCIATED WITH THIS ISSUE. SOFTWARE DEPLOYED TO ALL CENTERS IN JANUARY 2026 CORRECTED THE PROBLEM, AND REVIEWS CONFIRMED THE WORKFLOW CAN NO LONGER BE BYPASSED AND FOUND NO SIMILAR CASES. THIS IS BEING REPORTED AS AN MDR OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL IMPACT ON DONOR SAFETY AND UNIT SUITABILITY.

Additional Manufacturer Narrative

ON (B)(6) 2025, A BIOLIFE CENTER STAFF (USER) REPORTED A POTENTIAL SOFTWARE COMPLAINT THROUGH THE INTERNAL ONLINE HELPDESK. THE COMPLAINT INDICATED THAT A USER COULD BYPASS THE 'CDCS POSSIBLE MATCH FOUND' SCREEN, ALLOWING A DONOR BEING ABLE TO DONATE WITHOUT AN ENTRY BEING SAVED IN THE DIS DATABASE. INTENDED BEHAVIOR: WHEN DIS CONNECTS WITH CDCS TO CONFIRM THAT DONORS HAVE NOT DONATED AT ANOTHER PLASMA DONATION FACILITY, THE DIS DONOR SCREENING MODULE (V8.0.0.41) CROSS-CHECKS THE DONOR'S FIRST AND LAST NAME, GENDER, DATE OF BIRTH, AND DONOR ID AGAINST THE CDCS DATABASE. EXACT MATCHES ARE AUTOMATICALLY DEFERRED OR LABELLED AS A BIOLIFE DONATION (INTERNAL), WHILE PARTIAL MATCHES TRIGGER A 'CDCS POSSIBLE MATCH FOUND' SCREEN. WHEN THIS SCREEN APPEARS, THE USER MUST SELECT EITHER 'MATCH DEFER DONOR' OR 'NOT A MATCH,' AND THE ENTRY IS RECORDED IN THE DIS DATABASE. OBSERVED ISSUE: THE 'CDCS POSSIBLE MATCH FOUND' SCREEN CAN BE DISMISSED, ALLOWING THE USER TO BYPASS THE REQUIRED SELECTION. AS A RESULT, THE DONOR COULD PROCEED TO DONATE, AND NO ENTRY WOULD BE SAVED IN THE DIS DATABASE. ROOT CAUSE INVESTIGATION: A REVIEW OF THE IMPACTED DONOR SHOWED THAT A CDCS INQUIRY WAS RETURNED TO DIS ON (B)(6) 2025 (INQUIRY #0LRHZYK1) AS A 'CDCS POSSIBLE MATCH FOUND' WITH DONATIONS AT NON-BIOLIFE PLASMA CENTER(S) ON (B)(6) 2025. THIS SHOULD HAVE BEEN EVALUATED BY THE USER AND IDENTIFIED AS 'MATCH DEFER DONOR' AND THE DONOR SHOULD HAVE BEEN DEFERRED. DUE TO A DEVICE MALFUNCTION, THE USER WAS ABLE TO DISMISS THE INQUIRY AND DIS FAILED TO RETAIN THE EMPLOYEE'S EVALUATION FOR THE IDENTIFIED CDCS INQUIRY IN THE SYSTEM. THE ROOT CAUSE WAS DETERMINED TO BE CODE IN THE DIS DONOR SCREENING MODULE (V8.0.0.41) THAT ALLOWED THE 'CDCS POSSIBLE MATCH FOUND' SCREEN TO BE DISMISSED USING THE ESCAPE (ESC) KEY. THIS ALLOWED THE WORKFLOW TO BE BYPASSED AND PREVENTED THE CDCS POTENTIAL MATCH ENTRY FROM BEING SAVED IN THE DIS DATABASE. THE ISSUE WAS REPLICATED ONLY IN A TEST ENVIRONMENT USING THE ESC KEY. AN EXTENSIVE DATABASE RETROSPECTIVE REVIEW IDENTIFIED 13 DONORS WITH SIMILAR OCCURRENCES SINCE (B)(6) 2019, WHEN DIS DONOR SCREENING MODULE (V8.0.0.41) WENT LIVE. NO KNOWN ADVERSE EVENTS HAVE BEEN DIRECTLY ASSOCIATED WITH THIS ISSUE TO DATE. IN (B)(6) 2026, AN UPDATED VERSION OF DIS DONOR SCREENING MODULE (V 8.1.0.36) WAS DEPLOYED TO ALL CENTERS. IN THIS UPDATED VERSION, THE 'CDCS POSSIBLE MATCH FOUND' SCREEN CANNOT BE DISMISSED USING THE ESCAPE (ESC) KEY. THIS MDR IS BEING SUBMITTED OUTSIDE THE 30-DAY REPORTING TIMEFRAME. THE POTENTIAL ISSUE WAS INITIALLY IDENTIFIED ON (B)(6) 2025, AND A COMPREHENSIVE INVESTIGATION WAS INITIATED TO ASSESS THE SCOPE, ROOT CAUSE AND POTENTIAL RISK TO DONOR SAFETY AND PRODUCT SUITABILITY. THIS REPORT IS BEING SUBMITTED IN MARCH 2026 TO PROMOTE TRANSPARENCY AND TO NOTIFY FDA OF THE IDENTIFIED ISSUE, INVESTIGATION OUTCOMES AND CORRECTIVE ACTIONS TAKEN, DESPITE NO KNOWN ADVERSE EVENTS BEING ASSOCIATED WITH THE ISSUE. A DEVIATION WAS OPENED WITHIN THE QUALITY MANAGEMENT SYSTEM TO DOCUMENT THE INVESTIGATION, CORRECTIVE ACTIONS AND DELAYED MDR SUBMISSION. RISK ASSESSMENT: RISK ANALYSIS AND CONTROL PROCEDURES, INCLUDING REVIEW OF FAILURE MODE AND EFFECTS ANALYSES AND THE RISK ASSESSMENT AND CONTROL TABLE, DETERMINED THAT THE PRE-MITIGATION RISK WAS REMOTE IN OCCURRENCE AND SERIOUS IN SEVERITY, AS THE ISSUE COULD RESULT IN A DONOR DONATING THREE OR MORE TIMES WITHIN SEVEN DAYS. THIS RISK WAS MITIGATED WHEN THE DIS DONOR SCREENING MODULE WAS UPDATED TO V8.1 AND DEPLOYED ACROSS ALL CENTERS ON JANUARY 19, 2026. A CODE REVIEW CONFIRMED THAT THE CDCS POSSIBLE MATCH WORKFLOW CAN NO LONGER BE BYPASSED BY ANY MEANS, INCLUDING USE OF THE ESC KEY. IN ADDITION, A DATABASE REVIEW OF THE UPDATED DONOR SCREENING MODULE CONFIRMED THAT NO SIMILAR OCCURRENCES WERE IDENTIFIED. TESTING AND MONITORING: FOLLOWING DESIGN CONTROL PROCEDURES, VALIDATION WAS PERFORMED FOR THE DIS DONOR SCREENING MODULE (V8.1). QUALITY REVIEW AND APPROVAL CONFIRMED THAT THE UPDATED MODULE WAS APPROVED FOR IMPLEMENTATION IN PRODUCTION. POST-DEPLOYMENT ACTIVITIES WERE ALSO PERFORMED. DURING DEPLOYMENT, BIOLIFE IT AND THE QUALITY SYSTEM REPRESENTATIVE (QSR) CLOSELY MONITORED THE PERFORMANCE OF THE NEWLY DEPLOYED SOFTWARE THROUGH DAILY REVIEW OF ALL SUPPORT CALLS RECEIVED. ANY SOFTWARE ANOMALIES ENCOUNTERED WERE REVIEWED FOR IMPACT AND PROCESSED THROUGH THE COMPLAINT PROCESS. COMPLAINTS WERE RECEIVED, EVALUATED, INVESTIGATED, RESOLVED, AND REVIEWED. ANY REQUIRED CHANGES FOLLOWED THE CHANGE CONTROL PROCESS FOR ROUTINE OR URGENT UPDATES TO THE COMPUTERIZED SYSTEM. REGULATORY ASSESSMENT: UPDATING THE CODE WITHIN THE DIS DONOR SCREENING MODULE TO DISABLE BYPASS OF THE 'CDCS POSSIBLE MATCH FOUND' SCREEN DOES NOT MODIFY DIS'S INTENDED USE STATEMENT. A RISK-BASED ASSESSMENT WAS PERFORMED TO EVALUATE WHETHER THE IDENTIFIED HAZARDS AND HAZARDOUS SITUATIONS, AS WELL AS RISK ESTIMATION, ACCEPTABILITY, CONTROL MEASURES, RISK-BENEFIT ANALYSIS, AND OVERALL RISK EVALUATION, REMAINED ACCURATE. THE REVIEW DETERMINED THAT NO NEW HAZARDS OR HAZARDOUS SITUATIONS WERE INTRODUCED AND THAT THE RISK DOCUMENTATION REMAINED ACCURATE. ROUTINE VERIFICATION AND VALIDATION ACTIVITIES WERE COMPLETED. AFTER THOROUGH REVIEW, BIOLIFE DETERMINED THAT THIS CHANGE DOES NOT REQUIRE PREMARKET NOTIFICATION TO THE FDA. INSTEAD, TO COMPLY WITH 21 CFR PART 820, BIOLIFE DOCUMENTED THE CHANGE WITHIN THE QUALITY MANAGEMENT SYSTEM (QMS). ADDITIONAL INFORMATION ABOUT MDR WILL BE PROVIDED IN THE NEXT 510(K). NOTIFICATION: NO INTERVENTION OR ACTION WAS REQUIRED FROM USERS BECAUSE NO CENTERS ARE USING THE DIS DONOR SCREENING MODULE (V8.0.0.41), AND THE UPDATED MODULE DOES NOT ALLOW USERS TO BYPASS THE CDCS POSSIBLE MATCH WORKFLOW.