DONOR INFORMAITON SYSTEM (DIS)

Description of Event or Problem

ON (B)(6) 2026, AN ISSUE WAS IDENTIFIED IN THE DONOR SCREENING MODULE, VERSION V8.1.0.37, OF THE DONOR INFORMATION SYSTEM (DIS) WHERE THE DONOR ARM ACCEPTABILITY IS NOT REFLECTED ACCURATELY AFTER EVALUATION ON THE PRINTED LABEL ADDENDUM AND IN THE PHLEBOTOMY MODULE. IN (B)(6) 2025, BIOLIFE BEGAN DEPLOYMENT OF V8.1 OF THE DONOR SCREENING MODULE TO BIOLIFE PLASMA DONATION CENTERS. THE USER REPORTED THAT DIS WAS NOT CONSISTENTLY RETAINING MEDICAL SUPPORT SPECIALIST (MSS) INJECTION SITE DISAPPROVALS. CASES WERE REPORTED WHERE DONORS WERE DEEMED TO HAVE AN UNACCEPTABLE INJECTION SITE IN ONE ARM BY THE MSS; HOWEVER, DURING PHLEBOTOMY, THE DISAPPROVAL DID NOT APPEAR ON THE LABEL ADDENDUM, AND BOTH ARMS APPEARED TO BE APPROVED IN THE DONATION HISTORY REPORT (DHR) AND THE PHLEBOTOMY MODULE. THIS ISSUE WAS IDENTIFIED WHEN AN MSS RECOGNIZED THAT DONOR'S VENIPUNCTURES WERE, ON OCCASION, PERFORMED IN AN ARM THAT THEY HAD DISAPPROVED. THE ISSUE WAS REPLICATED IN A TEST ENVIRONMENT, A ROOT CAUSE INVESTIGATION WAS PERFORMED, AND A CORRECTION WAS IDENTIFIED AND IMPLEMENTED. THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO ANY SAFETY ISSUES FOR THE PLASMA OR DONORS. OUT OF EXTREME CAUTION, THIS EVENT WAS SUBMITTED AS A MEDICAL DEVICE REPORT (MDR).

Additional Manufacturer Narrative

ON (B)(6) 2026, A BIOLIFE PLASMA DONATION CENTER REPORTED THAT DIS WAS NOT CONSISTENTLY RETAINING MSS INJECTION SITE DISAPPROVALS. THE REPORT DESCRIBED CASES WHERE DONORS WERE APPROVED FOR DONATION WITH ONLY ONE ACCEPTABLE INJECTION SITE; HOWEVER, DURING PHLEBOTOMY, BOTH ARMS APPEARED AS ACCEPTABLE ON THE LABEL, IN THE DONATION HISTORY REPORT (DHR) AND IN THE PHLEBOTOMY MODULE. INTENDED BEHAVIOR: DURING DONOR SCREENING, THE MSS CONDUCTS AN EVALUATION OF VENIPUNCTURE SITE ACCEPTABILITY AND ENTERS ARM ACCEPTABILITY INTO THE DONOR SCREENING MODULE OF DIS. DIS SHOULD CORRECTLY REFLECT THE ARM ACCEPTABILITY FROM THE MSS EVALUATION ON THE PRINTED LABEL ADDENDUM AND WITHIN THE PHLEBOTOMY MODULE. THE PRINTED LABEL ADDENDUM AND THE DATA WITHIN THE PHLEBOTOMY MODULE COMMUNICATE THE ARM ACCEPTABILITY TO THE PHLEBOTOMIST. THE PRINTED LABEL ADDENDUM IS DISCARDED DURING UNIT AND SAMPLE PROCESSING. OBSERVED ISSUE: ON (B)(6) 2026, A BIOLIFE PLASMA DONATION CENTER REPORTED THAT DIS WAS NOT CONSISTENTLY RETAINING MSS INJECTION SITE DISAPPROVALS. THE REPORT DESCRIBED CASES WHERE DONORS WERE APPROVED FOR DONATION WITH ONLY ONE ACCEPTABLE INJECTION SITE; HOWEVER, DURING PHLEBOTOMY, BOTH ARMS APPEARED AS ACCEPTABLE ON THE LABEL, IN THE DONATION HISTORY REPORT (DHR) AND IN THE PHLEBOTOMY MODULE. ROOT CAUSE INVESTIGATION A CODE REVIEW OF THE DONOR SCREENING (V8.1.0.37) MODULE DETERMINED THE FOLLOWING: · THE ISSUE ORIGINATES FROM A BACKEND DATA MISINTERPRETATION OCCURRING PRIOR TO DATA SYNCHRONIZATION. · IN THE DONOR SCREENING MODULE, SCREENING STAFF AND MSS EVALUATE AND RECORD SPECIFIC PER-ARM ACCEPTABILITY (E.G., LEFTARM = NO, RIGHTARM = YES). · HOWEVER, THE FRONTEND (USER INTERFACE) ONLY TRANSMITS A SINGLE GENERIC VALUE (INJECTIONSITEAPPROVED = YES) EVEN THOUGH THE MSS PROVIDED PER ARM APPROVAL STATUS. · THE BACKEND API SUBSEQUENTLY MISINTERPRETS THIS SINGLE VALUE AS APPROVAL FOR BOTH ARMS, SETS BOTH INJECTION SITE LEFT AND RIGHT AS ACCEPTABLE AND DISCARDS THE ORIGINAL PER-ARM EVALUATION. · ONCE THE DATA SYNCHRONIZES THIS INCORRECT STATE TO THE DIS 8.0 DONATIONS TABLE, THE PRINTED LABEL ADDENDUM AND DONATION DETAIL SCREEN IN PHLEBOTOMY MODULE (WHICH BOTH RELY ON THIS TABLE) INCORRECTLY DISPLAY BOTH ARMS AS ACCEPTABLE. IT WAS CONFIRMED THAT IF BOTH ARMS ARE MARKED AS UNACCEPTABLE BY THE MSS, THE DONOR IS DEFERRED AND NOT ALLOWED TO DONATE. AFTER THE ROOT CAUSE WAS IDENTIFIED, THE ISSUE WAS REPLICATED IN A TEST ENVIRONMENT, WITH THE APPROVAL OF A SINGLE ARM IN DONOR SCREENING REFLECTING AS BOTH ARMS ACCEPTABLE ON THE PRINTED LABEL ADDENDUM AND THE DONATION DETAIL SCREEN IN THE PHLEBOTOMY MODULE. BOUNDING: BIOLIFE BEGAN DEPLOYMENT OF V8.1 OF THE DONOR SCREENING MODULE TO BIOLIFE PLASMA DONATION CENTERS ON SEPTEMBER 22, 2025. BASED ON REVIEW OF THE CODE FOR V8.1 OF THE DONOR SCREENING MODULE, BIOLIFE CONFIRMED THAT THE 8.0 VERSION OF THE DONOR SCREENING MODULE DID NOT HAVE THIS ISSUE. BIOLIFE HAS DEVELOPED A CHANGE TO ADDRESS THE ISSUE. THE CHANGE WAS REVIEWED, APPROVED, AND RELEASED IN DONOR SCREENING MODULE VERSION V8.1.0.42 TO ALL BIOLIFE PLASMA DONATION CENTERS ON (B)(6), 2026. RISK ASSESSMENT: PER THE MEDICAL ASSESSMENT, VENIPUNCTURE PERFORMED IN AN ARM DEEMED TO BE UNACCEPTABLE FOR VENIPUNCTURE IS NOT LIKELY TO RESULT IN SERIOUS INJURY OR DEATH. THEREFORE, THE POTENTIAL IMPACT TO DONOR SAFETY IS REMOTE. ANY POTENTIAL IMPACT TO DONOR SAFETY IS STRONGLY MITIGATED BY SOP-REQUIRED ASSESSMENTS, AS FOLLOWS: · THE MEDICAL HISTORIAN (MH) PERFORMS AN INITIAL ARM EVALUATION (B)(4) · IF A POTENTIAL ISSUE IS IDENTIFIED BY THE MH, THE DONOR IS REFERRED TO A MEDICAL SUPPORT SPECIALIST (MSS), WHO PERFORMS AN ARM ASSESSMENT AND DETERMINES ACCEPTABILITY TO DONATE AND ENTERS ARM ACCEPTABILITY INTO DIS AND APPROVES THE DONOR TO DONATE (B)(4) · A PHYSICAL ASSESSMENT OF THE ARM IS PERFORMED BY THE PHLEBOTOMIST PRIOR TO PERFORMING VENIPUNCTURE, IN ACCORDANCE WITH SOP AS FOLLOWS: · PHLEBOTOMISTS EVALUATE THE VENIPUNCTURE SITE WHEN SELECTING A SUITABLE VEIN AND AVOID AREAS WITH BRUISING, RASHES, TATTOOS, ETC. PER DONOR ARM PREPARATION, PHLEBOTOMY AND SAMPLE COLLECTION (B)(4) AND PHLEBOTOMY VEIN SELECTION, DONOR ARM PREPARATION AND VENIPUNCTURE WORK INSTRUCTION (B)(4). 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 A VENIPUNCTURE BEING PERFORMED ON A DONOR'S UNACCEPTABLE ARM (B)(4). THE FREQUENCY OF THE HAZARD WAS DETERMINED TO BE IMPROBABLE (EXTREMELY UNLIKELY TO OCCUR IN THE PROCESSING OF A SINGLE DONOR/UNIT OR POSSIBLE TO OCCUR THROUGHOUT BIOLIFE US). THE SEVERITY OF THE HAZARD WAS DETERMINED TO BE SERIOUS (POTENTIALLY RESULTS IN INJURY OR IMPAIRMENT NOT REQUIRING PROFESSIONAL MEDICAL INTERVENTION). THE RISK CONTROL MEASURES IDENTIFIED ABOVE ARE USED TO MITIGATE THE HAZARD TO AN ACCEPTABLE RISK. AS A RESULT OF THE REVIEW AND MEDICAL ASSESSMENT, THIS HAZARD WILL BE REVIEWED AND EVALUATED FOR REVISION TO THE DEVICE REQUIREMENT AND RISK DOCUMENTATION. TESTING AND MONITORING: AFTER THE ISSUE WAS IDENTIFIED, A CHANGE CONTROL WAS CREATED TO DOCUMENT THE CHANGE TO ADDRESS THE ROOT CAUSE. FOLLOWING INTERNAL DESIGN CONTROL PROCEDURES, VALIDATION WAS COMPLETED AND CONFIRMED THAT THE CHANGE RESOLVES THE ISSUE AND MEETS THE DEFINED SYSTEM REQUIREMENTS. THE CHANGE WAS REVIEWED, APPROVED AND RELEASED FOR IMPLEMENTATION IN PRODUCTION TO ALL BIOLIFE PLASMA DONATION CENTERS ON (B)(6) 2026. POST-DEPLOYMENT ACTIVITIES ARE BEING PERFORMED. DURING DEPLOYMENT, BIOLIFE IT AND THE QUALITY SYSTEM REPRESENTATIVE (QSR) CLOSELY MONITOR THE PERFORMANCE OF THE NEWLY DEPLOYED SOFTWARE TO REVIEW 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. TO DATE, NO NEW ISSUES RELATED TO THIS PROBLEM HAVE BEEN REPORTED. IF ADDITIONAL OCCURRENCES ARE IDENTIFIED, THE COMPLAINT PROCESS WILL BE FOLLOWED TO INVESTIGATE ANY POTENTIAL NEW ISSUES. REGULATORY ASSESSMENT: UPDATING THE ACCURATE APPROVAL STATUS OF BOTH ARMS ON THE PRINTED LABEL ADDENDUM AND WITHIN THE DONATION DETAILS SCREEN OF THE PHLEBOTOMY MODULE BASED UPON DOCUMENTATION AND EVALUATION FROM THE DONOR SCREENING MODULE 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 VENIPUNCTURE BEING PERFORMED ON A DONOR'S UNACCEPTABLE ARM. AFTER THOROUGH REVIEW, BIOLIFE DETERMINED THAT CHANGES MADE TO ADDRESS THE ISSUE DO 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 3016429887-2026-00005 WILL BE PROVIDED IN THE NEXT 510(K). THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO ANY SAFETY ISSUES FOR THE PLASMA OR DONORS. OUT OF EXTREME CAUTION, THIS EVENT WAS SUBMITTED AS A MEDICAL DEVICE REPORT (MDR). NOTIFICATION: 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. NO ADDITIONAL SOFTWARE UPGRADE OR USER FACILITY NOTIFICATION WAS REQUIRED TO MITIGATE THE REPORTED ISSUE, AS THE ISSUE HAS BEEN RESOLVED WITH THE UPDATED VERSION TO THE DONOR SCREENING MODULE (VERSION V8.1.0.42) THAT WAS DEPLOYED TO ALL BIOLIFE PLASMA DONATION CENTERS ON (B)(6) 2026. AS PART OF THE STANDARD SOFTWARE RELEASE PROCESS, BIOLIFE ISSUED A FORMAL RELEASE NOTIFICATION TO ALL BIOLIFE PLASMA DONATION CENTERS VIA EMAIL. THIS NOTIFICATION INCLUDED A DESCRIPTION OF SYSTEM CHANGES, THE DEPLOYMENT TIMELINE, ANY ACTIONS NEEDED FROM THE USER AND CONTACT INFORMATION FOR TECHNICAL SUPPORT. USERS ARE NOT REQUIRED TO APPLY OR IMPLEMENT SOFTWARE UPDATES. DIS IS A BLOOD ESTABLISHMENT COMPUTER SOFTWARE (BECS) DEVICE UTILIZED EXCLUSIVELY WITHIN BIOLIFE PLASMA DONATION CENTERS. BIOLIFE MAINTAINS FULL CONTROL OVER SOFTWARE DEVELOPMENT, VALIDATION, AND DEPLOYMENT. ALL SOFTWARE UPDATES AND PATCHES ARE CENTRALLY IMPLEMENTED AND VERIFIED BY BIOLIFE IN THE PRODUCTION ENVIRONMENT IN ACCORDANCE WITH ESTABLISHED PROCEDURES AND DO NOT REQUIRE ANY ACTION BY END USERS.