LOOKBACK NOTIFICATION SYSTEM (LNS)
Report
- Report Number
- 3016429887-2025-00002
- Event Type
- Malfunction
- Date Received
- June 26, 2025
- Date of Event
- June 4, 2025
- Report Date
- February 13, 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
BOUNDING: THERE WAS ONE (1) REPORTED COMPLAINT ASSOCIATED WITH THE IDENTIFIED PROBLEM. AS PART OF THE INTERNAL INVESTIGATION, THE BIOLIFE INFORMATION TECHNOLOGY (IT) TEAM PERFORMED A DATABASE REVIEW FROM APRIL 10, 2025 (THE DATE BIOLIFE FIRST IMPLEMENTED LNS VERSION 2.0) TO JUNE 13, 2025, TO IDENTIFY ADDITIONAL INSTANCES OF THE REPORTED ISSUE. OUT OF APPROXIMATELY 1900 LOOKBACKS GENERATED FOR THE REVIEWED PERIOD, THE INVESTIGATION IDENTIFIED ONE (1) DONATION THAT HAD A POSITIVE STS TEST RESULT, AN ADDITIONAL VIRAL MARKER RELEASED ON THE SAME DAY; THE TEST RESULTS WERE THE FIRST REACTIVE TEST RESULTS FOR A DONOR AND REQUIRED THE GENERATION OF EITHER A PDI OR PTR RECORD. LNS CHECKS IF A POST-DONATION INFORMATION (PDI) OR POSITIVE TEST RESULT (PTR) WAS CREATED. THE DONOR LISTED ABOVE HAD NO UNITS SHIPPED, AND A PTR WAS NOT REQUIRED. THE DONOR HAD COLLECTED UNITS AT MULTIPLE CENTERS, AND A PDI WAS INITIATED; THEREFORE, THE EXTENT OF THE ANALYSIS IS LIMITED TO THIS ONE DONOR WITH A PDI. A CONSIGNEE NOTIFICATION FOR THIS EVENT WAS NOT REQUIRED SINCE NO UNITS WERE SHIPPED AND THE UNITS WERE NOT USED FOR PRODUCTION. ROOT CAUSE INVESTIGATION: THE INVESTIGATION DETERMINED THAT THE ISSUE WAS RELATED TO PROCESSING AN INITIAL TEST RESULT FOR A SEROLOGIC TEST FOR SYPHILIS (STS) RESULT. LNS ONLY CHECKS IF A POST-DONATION INFORMATION (PDI) OR POSITIVE TEST RESULT (PTR) WAS CREATED FOR ATYA, BUT NOT FOR THE VIRAL MARKERS HIV, HCV, OR HBSAG. WHEN AN HIV, HCV, OR HBSAG RESULT IS REPORTED ON THE SAME DAY THAT AN STS RESULT IS REPORTED, LNS WILL CREATE THE PDI/PTR (WHEN APPLICABLE) FOR THE HIV, HCV, OR HBSAG TEST RESULT AND THEN OVERWRITE THE BRIEF DESCRIPTION AND SUMMARY OF INVESTIGATION FIELDS ONLY TO CONTAIN THE STS RESULT. SINCE THE INVESTIGATION SUMMARY FOR A PDI WAS NOT UPDATED FOR THE ADDITIONAL TEST RESULT, LNS FAILED TO MEET STEP 4 IN SECTION 2.7.1 OF THE LNS LOOKBACK NOTIFICATION DETAILED DESIGN DOCUMENT. TESTING WAS PERFORMED ON THE SUSPECTED DEVICE (LNS V2.0) IN A DEVELOPMENT ENVIRONMENT. THE TESTING REVEALED THAT BLEED NUMBERS WITH BOTH AN STS AND A VIRAL MARKER TEST RESULT RELEASED ON THE SAME DAY WILL ONLY DISPLAY STS RESULTS IF A PDI RECORD IS GENERATED (WHEN APPLICABLE). THE EVENT HISTORY LOG FOR PDI-25-PAZ-202 WAS REVIEWED. THE REVIEW DETERMINED THAT THE VIRAL MARKER PROCESSING WORKFLOW EXECUTED AT THAT TIME WAS OVERWRITTEN BY THE STS WORKFLOW, RESULTING IN ONLY THE STS RESULTS BEING CAPTURED ON THE PDI RECORD. THE CODE FOR LNS V2.0 WAS REVIEWED, AND IT WAS CONFIRMED THAT WHEN A BLEED NUMBER HAS BOTH AN STS AND A VIRAL MARKER TEST RESULT RELEASED ON THE SAME DAY, THE STS WORKFLOW WILL OVERWRITE THE PDI RECORD INSTEAD OF APPENDING THE RECORD. THE STS WORKFLOW CONFLICTS WITH THE VIRAL MARKER WORKFLOW WHEN POPULATING A PDI RECORD. A REVIEW WAS PERFORMED TO IDENTIFY ANY OTHER BLEED NUMBERS THAT MAY HAVE BEEN AFFECTED BY THIS ISSUE. THE REVIEW DID NOT IDENTIFY ANY OTHER DONORS THAT HAD BOTH AN STS AND A VIRAL MARKER TEST RESULT RELEASED ON THE SAME DAY THAT ALSO REQUIRED A PDI OR PTR TO BE INITIATED, INDICATING THAT PDI-25-PAZ-202 WAS THE FIRST AND ONLY OCCURRENCE TO DATE. THE ISSUE WAS ISOLATED TO THE ONE SOFTWARE CODING ISSUE DESCRIBED ABOVE. 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 STS AND A VIRAL MARKER IMPORTED ON THE SAME DAY. WHEN APPLICABLE, THE PDI RECORD WILL BE MANUALLY UPDATED BY IT TO INCLUDE THE MISSING VIRAL MARKER UNTIL A PERMANENT SOLUTION IS DEPLOYED. TESTING AND MONITORING: AFTER THE ISSUE WAS IDENTIFIED AND CORRECTED IN THE DEVELOPMENT ENVIRONMENT, TRACKWISE CHANGE CONTROL 5215177 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-019142 (GENERATING AND MONITORING IT QUERIES FOR SOFTWARE DEVICES), A DATABASE JOB 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 JOB 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 3016429887-2025-00002 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 HQ LOOKBACK DEPARTMENT WAS NOTIFIED OF THE ISSUE AND INFORMED THAT IT WILL QUERY AND CORRECT THE PDI 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.
UPDATES TO ROOT CAUSE INVESTIGATION IN SECTION H.10 OF THE INITIAL MDR: ORIGINAL LANGUAGE: THE INVESTIGATION DETERMINED THAT THE ISSUE WAS RELATED TO PROCESSING AN INITIAL TEST RESULT FOR A SEROLOGIC TEST FOR SYPHILIS (STS) RESULT. LNS ONLY CHECKS IF A POST-DONATION INFORMATION (PDI) OR POSITIVE TEST RESULT (PTR) WAS CREATED FOR ATYA, BUT NOT FOR THE VIRAL MARKERS HIV, HCV, OR HSAG. WHEN AN HIV, HCV, OR HBSAG RESULT IS REPORTED ON THE SAME DAY THAT AN STS RESULT IS REPORTED, LNS WILL CREATE THE PDI/PTR (WHEN APPLICABLE) FOR THE HIV, HCV, OR HBSAG TEST RESULT AND THEN OVERWRITE THE BRIEF DESCRIPTION AND SUMMARY OF INVESTIGATION FIELDS ONLY TO CONTAIN THE STS RESULT. ADDITION 1: AN ADDITIONAL SCENARIO WAS INVESTIGATED AS PART OF THE ORIGINAL DEVICE MALFUNCTION. IT WAS DETERMINED THAT, WHEN PROCESSING INITIAL STS TEST RESULTS, THE SYSTEM DOES NOT CHECK WHETHER A PDI OR PTR HAS BEEN CREATED FOR ATYA OR FOR THE VIRAL MARKERS (HIV, HCV, OR HBSAG). IF AN ATYA RESULT IS REPORTED ON THE SAME DAY AN STS RESULT IS IMPORTED, A PDI/PTR IS CREATED; HOWEVER, THE BRIEF DESCRIPTION AND SUMMARY OF INVESTIGATION FIELDS CONTAIN ONLY THE STS RESULT. THE BRIEF DESCRIPTION AND SUMMARY OF INVESTIGATION FIELDS SHOULD CONTAIN ALL TEST RESULTS. ADDITION 2: AN ADDITIONAL SCENARIO WAS INVESTIGATED AS PART OF THE ORIGINAL DEVICE MALFUNCTION. IT WAS DETERMINED THAT WHEN LNS IMPORTS MULTIPLE TEST RESULTS FOR THE SAME DONOR ON THE SAME RELEASE DATE (STS PLUS NON STS RESULTS SUCH AS VIRAL MARKERS OR ATYA), AND THE DONATION IMPACTS ANOTHER CENTER REQUIRING A PDI TO BE CREATED OR UPDATED, THE STS INITIAL AND/OR CONFIRMATORY RESULT UPDATE TAKES PRECEDENCE. AS A RESULT, THE BRIEF DESCRIPTION AND SUMMARY OF INVESTIGATION FIELDS DISPLAY ONLY THE STS RESULT, AND THE NON STS INITIAL AND/OR CONFIRMATORY RESULTS ARE NOT DISPLAYED.
DURING THE LOOKBACK REVIEW, THE LOOKBACK USER DISCOVERED THAT THE SUMMARY OF INVESTIGATION SECTION WITHIN A POST DONATION INFORMATION (PDI) RECORD DID NOT CONTAIN ALL THE TEST INFORMATION RECEIVED IN THE LOOKBACK NOTIFICATION SYSTEM (LNS). THE LOOKBACK USER UTILIZES THIS SECTION TO GENERATE CONSIGNEE NOTIFICATIONS FOR RELEASED UNITS THAT HAVE BEEN AFFECTED. THE INVESTIGATION (B)(6) DETERMINED THAT THE LNS SOFTWARE MALFUNCTION COULD AFFECT PROPER UNIT IDENTIFICATION. WHEN PROCESSING AN INITIAL TEST RESULT FOR A SEROLOGIC TEST FOR SYPHILIS (STS) RESULT, THE STS REACTIVE WORKFLOW ONLY CHECKS IF A POST-DONATION INFORMATION (PDI) OR POSITIVE TEST RESULT (PTR) WAS CREATED FOR AN ATYA RESULT, AND NOT FOR VIRAL MARKER RESULTS, SUCH AS HIV, HCV, OR HBSAG. WHEN AN HIV, HCV, OR HBSAG RESULT IS REPORTED ON THE SAME DAY THAT AN STS RESULT IS REPORTED, LNS WILL CREATE THE PDI/PTR (WHEN APPLICABLE) FOR THE HIV, HCV, OR HBSAG TEST RESULT AND THEN OVERWRITE THE BRIEF DESCRIPTION AND SUMMARY OF INVESTIGATION FIELDS ONLY TO CONTAIN THE STS RESULT. SINCE THE SUMMARY OF INVESTIGATION SECTION FOR A PDI WAS NOT UPDATED FOR THE ADDITIONAL TEST RESULT, LNS FAILED TO MEET STEP 4 IN SECTION 2.7.1 OF THE LNS LOOKBACK NOTIFICATION DETAILED DESIGN DOCUMENT. THE PDI RECORD WAS UPDATED TO INCLUDE THE MISSING TEST RESULT. THE PRODUCT TEAM IMPLEMENTED DAILY SCREENING TO IDENTIFY AND UPDATE FUTURE RECORDS THAT MAY CONTAIN THIS ISSUE. 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).
AS PART OF THE IMMEDIATE CORRECTIVE ACTION DESCRIBED IN SECTION H.10 OF THE INITIAL MDR, BIOLIFE IMPLEMENTED A DAILY QUERY TO SCREEN FOR DONORS WHOSE STS AND VIRAL MARKER RESULTS WERE IMPORTED ON THE SAME DAY. THIS QUERY IDENTIFIED NEW INFORMATION THAT WARRANTS CORRECTION OF DETAILS PREVIOUSLY REPORTED FOR THIS EVENT. THE DETAILS ARE PROVIDED IN SECTION H.10 OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1491415 | 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 | 38 YR | Female | Other |