DONOR INFORMATION SYSTEM (DIS)

Additional Manufacturer Narrative

ON (B)(6) 2026, A BIOLIFE CENTER STAFF (USER) REPORTED THAT WHEN APPLYING A TEMPORARY DEFERRAL REQUIRING A MANUALLY ENTERED OCCURRENCE DATE, THE SYSTEM DID NOT CALCULATE THE DEFERRAL EXPIRY DATE CORRECTLY. THE MANUALLY ENTERED OCCURRENCE DATE WAS (B)(6) 2026, AND THE CENTER INDICATED THAT THE APPLIED DEFERRAL (HEPATITIS B VACCINE) SHOULD HAVE RESULTED IN A 21-DAY DEFERRAL BUT DIS CALCULATED AN EXPIRY CONSISTENT WITH A 10-DAY DEFERRAL. INTENDED BEHAVIOUR: DIS SHOULD CORRECTLY APPLY TEMPORARY DEFERRALS THAT ARE BASED ON AN OCCURRENCE DATE SUCH THAT THE DEFERRAL EXPIRY DATE REFLECTS: · EXPIRY DATE = OCCURRENCE DATE + CONFIGURED DEFERRAL DAYS (FOR OCCURRENCE-BASED DEFERRALS). THIS ENSURES DONORS REMAIN DEFERRED FOR THE FULL REQUIRED PERIOD BEFORE BECOMING ELIGIBLE AGAIN. OBSERVED ISSUE: IN THE QUESTIONNAIRE REVIEW MODULE (V8.1.0.13), WHEN A USER SELECTS A TEMPORARY DEFERRAL REASON CODE ASSOCIATED WITH AN OCCURRENCE DATE, THE SYSTEM CALCULATES THE EXPIRY DATE INCORRECTLY, RESULTING IN A DEFERRAL PERIOD SHORTER THAN REQUIRED. EXAMPLE REPLICATION OUTCOME DOCUMENTED IN THE COMPLAINT SHOWED THAT FOR CODE 29506, A DONOR EXPECTED TO BE DEFERRED UNTIL (B)(6) 2026 (OCCURRENCE DATE (B)(6), 2026 + 21 DAYS) WAS INSTEAD DEFERRED UNTIL (B)(6) 2026. ROOT CAUSE INVESTIGATION: A CODE REVIEW OF THE QUESTIONNAIRE REVIEW (V8.1.0.13) MODULE DETERMINED THE FOLLOWING: · THE USER INTERFACE (UI) CALCULATES A "DAYS" VALUE AS: TODAY - OCCURRENCE DATE. · THE UI SENDS THIS CALCULATED "DAYS" VALUE TO THE DEFER APPLICATION PROGRAMMING INTERFACE (API). · THE DEFER API CALCULATES EXPIRY AS: EXPIRY DATE = TODAY + DAYS (FROM PAYLOAD). BECAUSE THE UI AND API INTERPRET "DAYS" DIFFERENTLY, THE RESULTING EXPIRY DATE CAN BE EARLIER THAN THE REQUIRED EXPIRY (OCCURENCE DATE + CONFIGURED DEFERRAL DURATION). A COMPARATIVE REVIEW OF OTHER MODULES IDENTIFIED DIFFERENT HANDLING OF OCCURRENCE-BASED DEFERRALS: · MANAGER'S CONSOLE (V8.0.0.45) AND MEDICAL (V8.0.0.41) SEND THE RAW OCCURRENCEDATE AND DEFERRAL DAYS TO THE API; WHEN AN OCCURRENCE DATE IS PROVIDED, THE API CORRECTLY COMPUTES EXPIRY AS OCCURRENCEDATE + DEFERRAL DAYS. · FOR CERTAIN WORKFLOWS (E.G., TATTOO/PIERCING IN MEDICAL V8.0.0.41), THE UI PRE-CALCULATES AND SENDS THE EXPIRY DATE DIRECTLY, WHICH IS CORRECT. BECAUSE OCCURRENCE-BASED EXPIRY CALCULATION IS CORRECT IN THE OTHER DIS MODULES, THIS CONFIRMS THE ISSUE IS ISOLATED TO THE QUESTIONNAIRE REVIEW MODULE. IT WAS CONCLUDED THAT THIS ISSUE WAS ASSOCIATED WITH THE DONOR SCREENING AND MONITORING CHANGES (BUILD 3 REV 0, DIS V8.0 BUILD 30, REV 0), WHICH WAS INITIALLY PILOTED IN (B)(6) 2025 AND ROLLED OUT IN PHASES. THE EARLIEST IMPACTED DONOR WAS IN (B)(6) 2025. ADDITIONALLY, THE INCORRECT EXPIRY CALCULATION CAN IMPACT THE DATE OCCURRED DISPLAYED ON THE DEFERRAL HISTORY REPORT (DEFERRALHISTORY.RDL, (B)(6) 2023), BECAUSE THE REPORT DERIVES DATE OCCURRED USING OCCURRENCE-BASED LOGIC AS DEFEXPIREDATE - CONFIGURED DEFERRAL DAYS. AFTER THE ROOT CAUSE WAS ISOLATED, THE ISSUE IN QUESTIONNAIRE REVIEW WAS REPLICATED IN A TEST ENVIRONMENT, AND DATABASE VERIFICATION WAS PERFORMED BY QUERYING TABLE CBR_TBLDEFERRALS TO COMPARE THE SYSTEM-CALCULATED DEFERRAL EXPIRY DATE VERSUS THE EXPECTED DATE. BOUNDING: THE INVESTIGATION IDENTIFIED 15 INDIVIDUALS DONATED A TOTAL OF 43 TIMES DURING A PERIOD WHEN A DEFERRAL SHOULD HAVE BEEN IN PLACE. A REVIEW OF AVAILABLE DATA DETERMINED THAT: · 11 OF THE 15 INDIVIDUALS DID NOT EXPERIENCE ANY ADVERSE EVENTS. · 3 INDIVIDUALS EXPERIENCED ADVERSE EVENTS; HOWEVER, THESE OCCURRED OUTSIDE THE TIME PERIOD ASSOCIATED WITH THE DEFERRAL ERROR AND WERE DETERMINED NOT TO BE ATTRIBUTABLE TO THE SYSTEM ISSUE. · 1 INDIVIDUAL EXPERIENCED THREE MINOR REACTIONS DURING THE PERIOD OF THE DEFERRAL ERROR. THESE REACTIONS WERE NON-SERIOUS, AND AN ALTERNATE CONTRIBUTING FACTOR WAS IDENTIFIED. OVERALL, ONLY ONE CASE OF MINOR REACTIONS OCCURRED DURING THE AFFECTED PERIOD, AND AN ALTERNATE CONTRIBUTING FACTOR WAS IDENTIFIED. THERE WAS NO EVIDENCE OF SERIOUS INJURY OR MEDICALLY SIGNIFICANT HARM. NO PATTERN OR TREND INDICATIVE OF BROADER SAFETY RISK WAS IDENTIFIED, AND THE ISSUE DID NOT DEMONSTRATE SYSTEMIC IMPACT ON DONOR SAFETY. THIS MDR IS BEING SUBMITTED OUTSIDE THE 30-DAY REPORTING TIMEFRAME. THE POTENTIAL ISSUE WAS INITIALLY IDENTIFIED ON (B)(6) 2026, AND A COMPREHENSIVE INVESTIGATION WAS INITIATED ON (B)(6) 2026 TO ASSESS THE SCOPE, ROOT CAUSE AND POTENTIAL RISK TO DONOR SAFETY AND PRODUCT SUITABILITY. AS THIS REPORT IS BEING SUBMITTED IN (B)(6) 2026, A DEVIATION WAS OPENED WITHIN THE QUALITY MANAGEMENT SYSTEM TO DOCUMENT THE INVESTIGATION, CORRECTIVE ACTIONS AND DELAYED MDR SUBMISSION. RISK ASSESSMENT: THIS ISSUE MAY IMPACT DONOR ELIGIBILITY AND UNIT SUITABILITY BECAUSE DONORS COULD POTENTIALLY BE PROCESSED FOR DONATION BEFORE COMPLETION OF THE REQUIRED DEFERRAL PERIOD. AFTER THE EVENT WAS SUBMITTED FOR MDR ASSESSMENT, A SUPPORT TEAM EMPLOYEE INITIATED A TRACKWISE RECORD TO DOCUMENT THE ISSUE. A DATABASE REVIEW WAS PERFORMED FOR TEMPORARY DEFERRALS APPLIED WITHIN THE CODE RANGE 29000-30000 TO ASSESS THE EXTENT OF THE ISSUE. A RISK ANALYSIS WAS CONDUCTED, INCLUDING REVIEW OF THE FAILURE MODES AND EFFECTS ANALYSES (FMEA) AND THE RISK ASSESSMENT AND CONTROL TABLE (RACT). THIS ANALYSIS CONFIRMED THAT THE ISSUE IS ENCOMPASSED WITHIN EXISTING HAZARDS RELATED TO AN INELIGIBLE DONOR DONATING. THE CURRENT HAZARD CONTROLS DO NOT FULLY ADDRESS THE SPECIFIC FAILURE MODE ASSOCIATED WITH INCORRECT CODE CALCULATION. ACCORDINGLY, A REFINEMENT TO THE EXISTING HAZARD CONTROL IS BEING DEVELOPED TO MORE EXPLICITLY ADDRESS THIS SCENARIO, AND A NEW HAZARD WILL BE CREATED AS NEEDED TO ENSURE THE REQUIREMENT IS FULLY ADDRESSED. THESE UPDATES WILL BE INCORPORATED WITHIN THE HAZARD FRAMEWORK AND TRACED TO THE APPLICABLE DIS REQUIREMENT. THIS ACTIVITY HAS BEEN PRIORITIZED AND IS IN PROGRESS. AS AN IMMEDIATE CORRECTIVE ACTION, AND IN ACCORDANCE WITH THE COMPANY'S INTERNAL PROCEDURES, BEGINNING (B)(6) 2026, IT SUPPORT PERFORMED DAILY MONITORING INVOLVING EXECUTION OF A SQL DATABASE QUERY TO IDENTIFY POTENTIALLY IMPACTED DONORS, COMMUNICATION OF RESULTS TO CENTERS, AND CENTER-LEVEL MANUAL REVALIDATION/CORRECTION OF DEFERRAL EXPIRY DATES. ADDITIONALLY, STARTING (B)(6) 2026, A TEMPORARY FIX WAS EXECUTED BY IT SUPPORT TO UPDATE INCORRECT DEFERRAL EXPIRY DATES. TESTING AND MONITORING: AFTER THE ISSUE WAS IDENTIFIED, A TRACKWISE CHANGE CONTROL WAS CREATED TO DOCUMENT THE CHANGE. THE FIX WAS PRIORITIZED AND IS CURRENTLY IN VALIDATION. FOLLOWING INTERNAL DESIGN CONTROL PROCEDURES, VALIDATION WILL CONFIRM THAT THE CHANGE RESOLVES THE ISSUE AND MEETS THE DEFINED SYSTEM REQUIREMENTS. UPON SUCCESSFUL VALIDATION, QUALITY WILL REVIEW AND APPROVAL THE CHANGE, AND IT WILL BE RELEASED FOR IMPLEMENTATION IN PRODUCTION. POST-DEPLOYMENT ACTIVITIES WILL ALSO BE PERFORMED. DURING DEPLOYMENT, BIOLIFE IT AND THE QUALITY SYSTEM REPRESENTATIVE (QSR) CLOSELY MONITOR THE PERFORMANCE OF THE NEWLY DEPLOYED SOFTWARE BY DAILY REVIEW OF ALL SUPPORT CALLS RECEIVED. ANY SOFTWARE ANOMALIES ENCOUNTERED ARE REVIEWED FOR IMPACT AND FOLLOW THE COMPLAINT PROCESS. COMPLAINTS ARE RECEIVED, EVALUATED, INVESTIGATED, RESOLVED, AND REVIEWED. ANY CHANGES FOLLOW THE CHANGE CONTROL PROCESS FOR ROUTINE OR URGENT CHANGES, IF REQUIRED, TO THE COMPUTERIZED SYSTEM. ADDITIONALLY, PER INTERNAL PROCEDURES, A DATABASE QUERY WAS CREATED TO MONITOR THE REPORTED ISSUE AND ENSURE THAT THE SOFTWARE RELEASE RESOLVES THE PROBLEM. IF ADDITIONAL OCCURRENCES ARE IDENTIFIED, THE COMPLAINT PROCESS WILL BE FOLLOWED TO INVESTIGATE ANY POTENTIAL NEW ISSUES. REGULATORY ASSESSMENT: UPDATING THE DEFERRAL CALCULATION WITHIN THE QUESTIONNAIRE REVIEW MODULE TO CORRECTLY CALCULATE THE EXPIRY DATE 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. THIS ANALYSIS CONFIRMED THAT THE ISSUE IS ENCOMPASSED WITHIN AN EXISTING HAZARD RELATED TO APPLICATION OF AN INCORRECT DEFERRAL CODE. THE CURRENT HAZARD CONTROL DOES NOT FULLY ADDRESS THE SPECIFIC FAILURE MODE ASSOCIATED WITH INCORRECT CODE CALCULATION. ACCORDINGLY, A REFINEMENT TO THE EXISTING HAZARD CONTROL IS BEING DEVELOPED TO MORE EXPLICITLY ADDRESS THIS SCENARIO, AND A NEW HAZARD WILL BE CREATED AS NEEDED TO ENSURE THE REQUIREMENT IS FULLY ADDRESSED. THESE UPDATES WILL BE INCORPORATED WITHIN THE HAZARD FRAMEWORK AND TRACED TO THE APPLICABLE DIS REQUIREMENT. ROUTINE VERIFICATION AND VALIDATION ACTIVITIES WILL BE 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 WILL BE PROVIDED IN THE NEXT 510(K). NOTIFICATION: INTERIM MITIGATION INCLUDED CENTER NOTIFICATION OF POTENTIALLY IMPACTED DONORS IDENTIFIED THROUGH DAILY MONITORING QUERIES, ENABLING CENTERS TO MANUALLY RE-VALIDATE AND CORRECT DEFERRAL EXPIRY DATES WHILE THE PERMANENT FIX IS IMPLEMENTED. IT SHOULD BE NOTED THAT DIS IS USED EXCLUSIVELY BY BIOLIFE PLASMA SERVICES, L.P., AND IS NOT MARKETED TO THIRD PARTIES. AS A RESULT, THE COMPANY'S IT GROUP MAINTAINS DIRECT OVERSIGHT OF DIS.

Description of Event or Problem

AN ISSUE WAS IDENTIFIED IN THE DONOR INFORMATION SYSTEM (DIS) QUESTIONNAIRE REVIEW MODULE (V8.1.0.13) WHERE TEMPORARY DEFERRALS WITH REASON CODES IN THE 29000-30000 RANGE THAT REQUIRE A MANUALLY ENTERED OCCURRENCE DATE MAY HAVE AN INCORRECTLY CALCULATED DEFERRAL EXPIRY DATE. IN THE REPORTED CASE, A DONOR DISCLOSED RECEIVING A HEPATITIS B VACCINE ON (B)(6) 2026, WHICH PER MEDICAL AFFAIRS GUIDANCE (MAG) REQUIRES A 21-DAY DEFERRAL. HOWEVER, APPLICATION OF DEFERRAL CODE 29506 RESULTED IN A 10-DAY DEFERRAL (DIS EXPIRY CALCULATED AS (B)(6) 2026, RATHER THAN THE EXPECTED (B)(6) 2026). CENTER STAFF IDENTIFIED THE INCORRECT DEFERRAL TIMEFRAME AND CORRECTED THE DEFERRAL; THE DONOR DID NOT RETURN EARLY TO DONATE. IF UNCORRECTED, THIS ISSUE COULD ALLOW A DONOR TO BE PROCESSED FOR DONATION BEFORE THE REQUIRED DEFERRAL PERIOD IS COMPLETE, IMPACTING DONOR ELIGIBILITY AND UNIT SUITABILITY. THE ISSUE WAS REPLICATED IN A TEST ENVIRONMENT, AND INTERIM MONITORING/CORRECTION ACTIVITIES WERE IMPLEMENTED WHILE A PERMANENT FIX IS PURSUED.