LOOKBACK NOTIFICATION SYSTEM (LNS)
Report
- Report Number
- 3016429-2026-00001
- Event Type
- Malfunction
- Date Received
- January 2, 2026
- Date of Event
- December 4, 2025
- Report Date
- January 2, 2026
- Manufacturer
- BIOLIFE PLASMA SERVICES L.P.
- Product Code
- MMH
- PMA / PMN Number
- BK241136
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
ON (B)(6) 2025, DURING VALIDATION TESTING OF A DEVICE ENHANCEMENT, AN ISSUE WAS IDENTIFIED IN THE LOOKBACK NOTIFICATION SYSTEM VERSION 2.0 (LNS) DURING VALIDATION TESTING: AUTOMATED PROCESSING OF POSITIVE TEST RESULTS DOES NOT GENERATE A POST DONATION INFORMATION RECORD AT AN ADDITIONAL IMPACTED CENTER FOR POSITIVE SEROLOGIC SYPHILIS TEST RESULTS WHEN A POSITIVE TEST RESULT ALREADY EXISTS FOR THE DONOR AT THAT IMPACTED CENTER, EVEN WHEN NEWLY IDENTIFIED IMPACTED UNITS FALL OUTSIDE THE EXISTING POSITIVE TEST RESULT'S IMPACTED DONATION DATE RANGE. ON (B)(6) 2025, THE LNS TEAM CONFIRMED THE ISSUE WAS NOT DUE TO VALIDATION TESTING; INSTEAD, THE SYSTEM REQUIREMENT IS INCOMPLETE AND DOES NOT MEET THE BUSINESS NEED. A COMPLAINT WAS OPENED AND AN MDR ASSESSMENT AS PERFORMED PER INTERNAL PROCEDURES. INTENDED BEHAVIOR (ALL TEST TYPES): WHEN AUTOMATED PROCESSING OF POSITIVE TEST RESULTS PROCESSES AN UNSUITABLE TEST RESULT AT THE INITIAL CENTER, LNS EVALUATES IMPACTED UNITS AT OTHER CENTERS. FOR EACH IMPACTED CENTER, IT CHECKS WHETHER AN EXISTING POSITIVE TEST RESULT COVERS THE IMPACTED DONATION DATE RANGE: IF THE EXISTING POSITIVE TEST RESULT DATE RANGE COVERS THE NEWLY IMPACTED DONATION DATE RANGE, NO NEW POST DONATION INFORMATION RECORD IS CREATED. IF THE NEWLY IMPACTED DONATION DATE RANGE FALLS OUTSIDE THE EXISTING POSITIVE TEST RESULT DATE RANGE, THE SYSTEM CREATES A POST DONATION INFORMATION RECORD. OBSERVED ISSUE: FOR SEROLOGICAL SYPHILIS TEST TYPES, THE SECOND CONDITION DOES NOT FUNCTION AS INTENDED; THE SYSTEM DOES NOT CREATE A POST DONATION INFORMATION RECORD AT THE IMPACTED CENTER WHEN ADDITIONAL IMPACTED UNITS ARE IDENTIFIED THAT ARE NOT COVERED BY THE EXISTING POSITIVE TEST RESULT. ROOT CAUSE INVESTIGATION: THE INVESTIGATION DETERMINED THE ISSUE WAS RELATED TO AN INCOMPLETE SYSTEM REQUIREMENT: LNS DOES NOT GENERATE POST DONATION INFORMATION RECORDS AT IMPACTED CENTERS WHEN ADDITIONAL IMPACTED UNITS ARE IDENTIFIED FOR POSITIVE SEROLOGICAL SYPHILIS TEST RESULTS AND THOSE UNITS FALL OUTSIDE THE DATE RANGE COVERED BY AN EXISTING POSITIVE TEST RESULT. A RETROSPECTIVE REVIEW OF PERMANENT DONOR NUMBERS PROCESSED IN LNS VERSION 2.0 SINCE THE SYSTEM WAS RELEASED IN (B)(6) 2025 INVOLVING POSITIVE SEROLOGICAL SYPHILIS TEST RESULTS AND IMPACTED UNITS AT ANOTHER CENTER CONFIRMED THAT AFFECTED UNITS WERE IDENTIFIED AND MANAGED APPROPRIATELY THROUGH AN ASSOCIATED POSITIVE TEST RESULT AND/OR EXISTING POST DONATION INFORMATION RECORD. NO COMPLAINTS WERE REPORTED. OTHER TEST TYPES WERE REVIEWED AND THE ISSUE WAS DETERMINED TO BE LIMITED TO SYPHILIS TEST RESULTS. POST DONATION INFORMATION RECORDS WERE INITIATED AS REQUIRED FOR ALL OTHER TEST TYPES AND LNS IS FUNCTIONING AS INTENDED. TO MEET THE REQUIREMENT, LNS WILL BE UPDATED TO ENSURE POST DONATION INFORMATION RECORDS ARE GENERATED FOR POSITIVE SYPHILIS TEST RESULTS WHEN NEWLY IDENTIFIED IMPACTED UNITS ARE NOT COVERED BY AN EXISTING POSITIVE TEST RESULT DATE RANGE. THE EVENT WAS IDENTIFIED INTERNALLY BY OUR SYSTEM DEVELOPMENT TEAM AND DID NOT CAUSE OR CONTRIBUTE TO ANY SAFETY ISSUES FOR PLASMA UNITS OR DONORS. OUT OF AN ABUNDANCE OF CAUTION, IT WAS SUBMITTED AS A MEDICAL DEVICE REPORT (MDR). RISK ASSESSMENT: FOR THE REPORTED DEVICE PROBLEM, THE DESIGN AND USE/MISUSE FMEAS, ALONG WITH THE RISK ASSESSMENT AND CONTROL TABLE (RACT) WERE REVIEWED. THE RACT HAS AN IDENTIFIED HAZARD (LNS.HAZ.002) READING "AS A RESULT OF POST-DONATION INFORMATION (PDI) INCLUDING A DONOR DIAGNOSED WITH CJD/VCJD) OR NON-CONFORMING EVENT, AN UNSUITABLE UNIT IS RELEASED TO THE MANUFACTURER." 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). RISK CONTROL MEASURES IDENTIFIED TO MITIGATE THE HAZARD TO AN ACCEPTABLE RISK ARE: 1. THE SYSTEM ALLOWS THE USER TO CREATE AN ELECTRONIC LOOKBACK NOTIFICATION RECORD OF THE UNSUITABLE UNIT TO BE SENT TO CONSIGNEES FOR DESTRUCTION. 2. THE SYSTEM HAS THE ABILITY TO AUTOMATICALLY CALCULATE AFFECTED BLEED DATE RANGES FOR COMMON TYPES OF POST DONATION INFORMATION (PDI) LOOKBACKS, REDUCING THE CHANCE OF A USER MISCALCULATING THE AFFECTED RANGE MANUALLY. AS AN IMMEDIATE CORRECTIVE ACTION, AND IN ACCORDANCE WITH THE COMPANY'S PLASMA DERIVED THERAPIES (PDT) IT DATABASE CHANGES SOP-243637, A DAILY QUERY WAS IMPLEMENTED TO SCREEN FOR DONORS WHO HAVE A STS TEST RESULT RECORD CREATED AT AN IMPACTED CENTER. WHEN APPLICABLE, THE POST DONATION INFORMATION RECORD WILL BE MANUALLY UPDATED BY THE BIOLIFE IT TEAM TO INCLUDE THE MISSING VIRAL MARKER UNTIL A PERMANENT SOLUTION IS DEPLOYED. TESTING AND MONITORING: AFTER THE ISSUE WAS IDENTIFIED, A TRACKWISE CHANGE CONTROL WAS CREATED TO DOCUMENT THE CHANGE. FOLLOWING CHANGE CONTROL AND DESIGN CONTROL PROCEDURES, VALIDATION WILL BE PERFORMED TO CONFIRM THE CHANGE RESOLVED THE ISSUE AND MET THE DEFINED SYSTEM REQUIREMENTS. THE QUALITY REVIEW AND APPROVAL OF THE CHANGE WILL CONFIRM THAT THE CORRECTION RESOLVED THE ISSUE, AND THE CHANGE WILL BE APPROVED 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, BY SOP-01914 (GENERATING AND MONITORING IT QUERIES FOR SOFTWARE DEVICES), A DATABASED QUERY WAS CREATED TO MONITOR THE REPORTED ISSUE AND ENSURE THAT THE SOFTWARE RELEASE RESOLVES THE PROBLEM. WHEN THE CHANGES ARE APPROVED AND IMPLEMENTED IN PRODUCTION, THE QUERY WILL BE REVIEWED TO CONFIRM THAT NO ADDITIONAL OCCURRENCES HAVE OCCURRED AFTER THE SOFTWARE VERSION WAS RELEASED. IF ADDITIONAL OCCURRENCES ARE IDENTIFIED, THE COMPLAINT PROCESS WILL BE FOLLOWED TO INVESTIGATE ANY POTENTIAL NEW ISSUES. REGULATORY ASSESSMENT: UPDATING THE LNS INFORMATION SUMMARY SECTION DOES NOT MODIFY LNS'S INTENDED USE STATEMENT. A RISK-BASED ASSESSMENT WAS PERFORMED TO EVALUATE WHETHER THE HAZARDS AND HAZARDOUS SITUATIONS, AS WELL AS RISK ESTIMATION, ACCEPTABILITY, CONTROL, RISK-BENEFIT ANALYSIS, AND OVERALL RISK EVALUATION, WERE STILL ACCURATE. UPON COMPLETION OF THE REVIEW, IT WAS DETERMINED THAT NO NEW HAZARDS OR HAZARDOUS SITUATIONS WERE IDENTIFIED, AND THE RISK DOCUMENTATION REMAINED ACCURATE. ROUTINE VERIFICATION AND VALIDATION ACTIVITIES WILL BE COMPLETED. AFTER A THOROUGH REVIEW, BIOLIFE DETERMINED THAT THIS CHANGE DOES NOT REQUIRE A PREMARKET NOTIFICATION TO THE FDA. INSTEAD, TO COMPLY WITH 21 CFR PART 820, BIOLIFE DOCUMENTED THE CHANGE IN THE QUALITY MANAGEMENT SYSTEM (QMS). ADDITIONAL INFORMATION ABOUT MDR 3016429887-2025-00004 WILL BE DESCRIBED IN THE NEXT 510(K). NOTIFICATION: NO INTERVENTION OR ACTION WAS REQUIRED FROM THE CENTER USERS, AS PROPER UNIT IDENTIFICATION AND DONOR DEFERRAL ARE STILL BEING HANDLED APPROPRIATELY WHEN DIS IMPORTS THE REACTIVE TESTS. AS A RESULT, IT WAS DETERMINED THAT THERE WAS NO NEED TO INFORM THE CENTER USERS AS AN IMMEDIATE CORRECTIVE ACTION. THE HEADQUARTERS LOOKBACK DEPARTMENT WAS NOTIFIED OF THE ISSUE AND INFORMED THAT IT WILL QUERY AND CORRECT THE POST DONATION INFORMATION RECORDS AFFECTED BY THIS ISSUE DAILY. IT SHOULD BE NOTED THAT LNS 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 LNS.
IT WAS FOUND THAT AUTOMATED PROCESSING OF POSITIVE TEST RESULTS IN LOOKBACK NOTIFICATION SYSTEM VERSION 2.0 (LNS) DOES NOT GENERATE A POST DONATION INFORMATION RECORD AT AN ADDITIONAL IMPACTED CENTER FOR POSITIVE SEROLOGIC SYPHILIS TEST RESULTS WHEN A POSITIVE TEST RESULT ALREADY EXISTS FOR THE DONOR AT THAT IMPACTED CENTER, EVEN WHEN NEWLY IDENTIFIED IMPACTED UNITS FALL OUTSIDE THE EXISTING POSITIVE TEST RESULT'S IMPACTED DONATION DATE RANGE. TO MEET THE BUSINESS REQUIREMENT, LNS WILL BE UPDATED TO ENSURE POST DONATION INFORMATION RECORDS ARE GENERATED FOR POSITIVE SYPHILIS TEST RESULTS WHEN NEWLY IDENTIFIED IMPACTED UNITS ARE NOT COVERED BY AN EXISTING POSITIVE TEST RESULT RANGE. A RETROSPECTIVE REVIEW OF PERMANENT DONOR NUMBERS PROCESSED IN LNS VERSION 2.0 SINCE SYSTEM RELEASE IN (B)(6) 2025 INVOLVING POSITIVE SEROLOGICAL SYPHILIS TEST RESULTS AND IMPACTED UNITS AT ANOTHER CENTER CONFIRMED THAT AFFECTED UNITS WERE IDENTIFIED AND MANAGED APPROPRIATELY THROUGH AN ASSOCIATED POSITIVE TEST RESULT AND/OR EXISTING POST DONATION INFORMATION RECORD. NO COMPLAINTS WERE REPORTED. THE EVENT WAS IDENTIFIED BY OUR INTERNAL DEVELOPMENT TEAM AND DID NOT CAUSE OR CONTRIBUTE TO ANY SAFETY ISSUES FOR PLASMA UNITS OR DONORS. OUT OF AN ABUNDANCE OF CAUTION, IT WAS SUBMITTED AS A MEDICAL DEVICE REPORT (MDR).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10199 | LOOKBACK NOTIFICATION SYSTEM (LNS) | Blood Establishment Computer Software and Accessories | MMH | BIOLIFE PLASMA SERVICES L.P. | VERSION 2.0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |