FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM
Report
- Report Number
- 3004548776-2025-00604
- Event Type
- Death
- Date Received
- November 24, 2025
- Date of Event
- October 26, 2025
- Report Date
- January 28, 2026
- Manufacturer
- FENWAL INTERNATIONAL INC.
- Product Code
- GKT
- UDI-DI
- 04086000101356
- PMA / PMN Number
- BK110072
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ON 27 OCTOBER 2025, FRESENIUS KABI CANADA WAS NOTIFED BY A CUSTOMER ((B)(6)) OF A SERIOUS ADVERSE EVENT. ON (B)(6) 2025, (B)(6) LEARNED OF THE DEATH OF A 22-YEAR-OLD FEMALE, FIRST TIME DONOR WHO HAD ATTENDED THE (B)(6) THE PREVIOUS DAY. BASED ON DETAILS FROM (B)(6), ABOUT 45 MINUTES INTO THE PROCEDURE THE DONOR EXPERIENCED A LOSS OF CONSCIOUSNESS FOLLOWED BY CONVULSIONS. EMERGENCY SERVICES WERE CONTACTED, AND THE DONOR WAS TRANSPORTED TO HOSPITAL WHERE SHE WAS LATER PRONOUNCED DEAD WITHOUT HAVING REGAINED CONSCIOUSNESS (EXACT TIME OF DEATH UNKNOWN). (B)(6) REPORTED THAT THE CUSTOMER SHOWED NO ADVERSE SIGNS OR SYMPTOMS PRIOR TO THE LOSS OF CONSCIOUSNESS, AND THE SELF-COMPLETED DONOR QUESTIONNAIRE DID NOT DISCLOSE ANY MEDICAL CONDITIONS, MEDICATIONS, SURGERIES, ALLERGIES OR ANY OTHER INFORMATION WHICH WOULD HAVE DISQUALIFIED DONATION. NO FURTHER MEDICAL INFORMATION IS AVAILABLE AT THIS TIME, INCLUDING THE OFFICIAL CAUSE OF DEATH. DONOR HEIGHT (CM): 165 DONOR WEIGHT (KG): 110 SCREENING BLOOD PRESSURE: 125/74 SCREENING PULSE: 76 SCREENING HCT: 38.80% SCREENING TOTAL PROTEIN: 7.70G/DL INSTRUMENTATION: THE DONATION WAS USED THE FOLLOWING FRESENIUS KABI PRODUCTS: - AURORA PLASMAPHERESIS DEVICE (MODEL 6R4601, S/N (B)(6)) - PLASMACELL-C DISPOSABLE SET (CODE 4R2256, LOT FA25E28068) - ANTICOAGULANT SODIUM CITRATE SOLUTION, USP (CODE C6B7801, LOT 24EG04019) - PLASMALINK POOLING BOTTLE (CODE 6R2069, LOT FA25D30083) * ANTISEPTIC, SALINE AND NEEDLE USED WERE NON-FRESENIUS KABI PRODUCTS. (B)(6) HAS REPORTED THAT SAMPLES OF THE PLASMACELL-C DISPOSABLE SET AND ANTICOAGULANT SODIUM CITRATE SOLUTION, USP USED FOR THE SPECIFIED DONOR WERE UNAVAILABLE FOR RETURN. THE PLASMALINK POOLING BOTTLE WAS AVAILABLE BUT STILL CONTAINED PLASMA AND MAY BE REQUIRED BY THE MEDICAL EXAMINER OR HEALTH CANADA, THEREFORE MAY NOT BE AVAILABLE FOR FRESENIUS KABI'S INVESTIGATION. THE PLASMAPHERESIS DEVICE WAS PLACED ON HOLD FOR EVALUATION. ON (B)(6) 2025, A FRESENIUS KABI TECHNICIAN EXAMINED THE DEVICE ON SITE, VERIFIED ALL FUNCTIONS AND OPERATIONS AS PER THE TPDS CHECKLIST WITH NO ISSUES IDENTIFIED, AND DOWNLOADED THE DEVICE HISTORY LOGS. NO DEVICE ANOMALIES WERE IDENTIFIED. DETAILED LOG FILE ANALYSIS FOR THE DAY OF DONATION CONFIRMED PROPER SYSTEM PERFORMANCE, WITH ALL SAFETY AND PRESSURE ALARMS FUNCTIONING AS INTENDED. (B)(6) IS RESPONSIBLE FOR MAINTAINING PREVENTIVE MAINTENANCE AND SERVICE DOCUMENTATION FOR THEIR INSTRUMENTS. FRESENIUS KABI DOES NOT RETAIN PRIOR SERVICE HISTORY FOR THIS SERIAL NUMBER BEYOND THE TECHNICAL PERFORMANCE AND DIAGNOSTIC SERVICE (TPDS) AND LOG FILE EXPORT PERFORMED ON (B)(6) 2025. WEIGH SCALE VERIFICATION RECORDS INDICATE DAILY CHECKS PASSED FROM (B)(6) THROUGH (B)(6) 2025. SIX OF FORTY-FOUR DAYS SHOWED INITIAL READINGS DEVIATING BY NO MORE THAN +3 G FROM THE ACCEPTABLE RANGE, ALL CORRECTED UPON RECHECK. REVIEW OF THE HISTORY LOGS DETERMINED THERE WERE FIVE (5) PROCEDURES PERFORMED ON THE DATE IN QUESTION, AND IN ALL 5 PROCEDURES, THERE WAS NO INDICATION OF ANY ANOMALIES OR DEVICE MALFUNCTION. THE FIRST 4 PROCEDURES WERE UNREMARKABLE; HOWEVER, THE FINAL PROCEDURE OF THE DAY WAS TERMINATED WITH SEVERAL VEIN OCCLUSIONS DURING BOTH DRAW AND RETURN. BASED ON ADDITIONAL INFORMATION SUBSEQUENTLY RECEIVED FROM (B)(6), IT WAS CONFIRMED THAT THE ADVERSE EVENT OCCURRED DURING THIS FINAL PROCEDURE. REVIEW OF THE LOG FOR THIS 5TH PROCEDURE DETERMINED THE TOTAL TIME WAS 47.5 MINUTES, WITH 4 COMPLETED CYCLES AND 1 INCOMPLETE CYCLE. 10/500ML SALINE WAS USED FOR PRIMING AND 107ML OF ANTICOAGULANT (6:100 RATIO) WAS INFUSED. 1606ML OF WHOLE BLOOD WAS PROCESSED WITH 586/933ML PLASMA WITH ANTICOAGULANT COLLECTED. MULTIPLE OCCLUSION ALERTS WERE RECORDED DURING THE PROCEDURE: TWO DRAW OCCLUSION ALERTS [3508] IN CYCLES 3 AND 5, TWO RETURN OCCLUSION ALERTS [3602] IN CYCLE 1, AND ONE RETURN OCCLUSION ALERT [3603] IN CYCLE 5. OCCLUSIONS WERE DETECTED AT INTENDED PRESSURES, AND FLOW APPROPRIATELY STOPPED EACH TIME. FLOW RATES WERE ADJUSTED THROUGHOUT THE PROCEDURE IN RESPONSE TO OR ANTICIPATION OF OCCLUSIONS. THE DRAW RATE WAS REDUCED FROM 90 TO 60 ML/MIN WITHIN THE FIRST MINUTE AND SUBSEQUENTLY VARIED BETWEEN 40-80 ML/MIN. THE RETURN RATE RANGED FROM 70-100 ML/MIN. P2 (TRANSMEMBRANE) PRESSURES WERE VARIABLE BUT NOT ATYPICAL GIVEN THE FLOW CHANGES. P3 (CUFF) PRESSURE DEMONSTRATED A TRANSIENT ELEVATION AT THE END OF CYCLE 1, LIKELY RELATED TO CUFF INFLATION TO CHECK NEEDLE POSITION. THE WEIGHT SCALE, HEMOGLOBIN DETECTOR, AND RESERVOIR SENSORS SHOWED NORMAL SIGNAL PATTERNS. THE AURORA INSTRUMENT FUNCTIONED AS INTENDED, AND NO PROCEDURAL DEVIATIONS, DEVICE MALFUNCTIONS, OR MATERIAL DEFECTS WERE IDENTIFIED THAT WOULD BE EXPECTED TO CONTRIBUTE TO THE DONOR'S COLLAPSE. IN THE ABSENCE OF MEDICAL AND POST-MORTEM FINDINGS, THE RELATIONSHIP BETWEEN THE PLASMAPHERESIS PROCEDURE AND THE DONOR'S DEATH CANNOT BE DETERMINED. SUMMARY OF COMPLAINT INVESTIGATION RESULTS TO DATE · AURORA PLASMAPHERESIS DEVICE WAS EVALUATED AND FOUND TO BE WORKING AS INTENDED. · NO SIMILAR COMPLAINTS/RELATED ADVERSE EVENTS RECEIVED BY THE FABRICATORS OF THE PLASMACELL-C DISPOSABLE SET, PLASMALINK POOLING BOTTLE (HAINA), AND ANTICOAGULANT SODIUM CITRATE SOLUTION, USP ((B)(6)). · MEDICAL INFORMATION REGARDING THE DONOR IS CURRENTLY UNAVAILABLE. THE DEVICE AND DISPOSABLE COMPONENTS PERFORMED AS INTENDED. THE CAUSAL RELATIONSHIP BETWEEN THE PLASMAPHERESIS PROCEDURE AND THE DONOR FATALITY REMAINS INCONCLUSIVE PENDING RECEIPT OF ADDITIONAL MEDICAL INFORMATION (SUCH AS MEDICAL RECORDS AND AUTOPSY RECORD). THIS REPORT IS BEING SUBMITTED CONSERVATIVELY WHILE FRESENIUS KABI AWAITS MORE INFORMATION.
ON 27 OCTOBER 2025, FRESENIUS KABI CANADA WAS NOTIFED BY A CUSTOMER ((B)(6)) OF A SERIOUS ADVERSE EVENT. ON (B)(6) 2025, (B)(6) LEARNED OF THE DEATH OF A 22-YEAR-OLD FEMALE, FIRST TIME DONOR WHO HAD ATTENDED THE WINNIPEG PLASMA DONATION CENTRE THE PREVIOUS DAY. BASED ON DETAILS FROM (B)(6), ABOUT 45 MINUTES INTO THE PROCEDURE THE DONOR EXPERIENCED A LOSS OF CONSCIOUSNESS (LOC) FOLLOWED BY CONVULSIONS. EMERGENCY SERVICES WERE CONTACTED, AND THE DONOR WAS TRANSPORTED TO HOSPITAL WHERE SHE WAS LATER PRONOUNCED DEAD WITHOUT HAVING REGAINED CONSCIOUSNESS (EXACT TIME OF DEATH UNKNOWN). (B)(6) REPORTED THAT THE CUSTOMER SHOWED NO ADVERSE SIGNS OR SYMPTOMS PRIOR TO THE LOSS OF CONSCIOUSNESS, AND THE SELF-COMPLETED DONOR QUESTIONNAIRE DID NOT DISCLOSE ANY MEDICAL CONDITIONS, MEDICATIONS, SURGERIES, ALLERGIES OR ANY OTHER INFORMATION WHICH WOULD HAVE DISQUALIFIED DONATION. PLEASE NOTE, THIS EVENT OCCURRED IN CANADA. MEDICAL RECORDS AND AUTOPSY REPORTS HAVE NOT BEEN MADE AVAILALE TO FRESENIUS KABI CANADA. PROVISIONAL PRIVACY LAWS PRECLUDE FRESNIUS KABI FROM OBTAINING THIS INFORMATION. DONOR HEIGHT (CM): 165 DONOR WEIGHT (KG): 110 SCREENING BLOOD PRESSURE: 125/74 SCREENING PULSE: 76 SCREENING HCT: 38.80% SCREENING TOTAL PROTEIN: 7.70G/DL INSTRUMENTATION: THE DONOR'S FINAL DONATION USED THE FOLLOWING FRESENIUS KABI PRODUCTS: - AURORA PLASMAPHERESIS DEVICE (MODEL 6R4601, S/N (B)(6)) - PLASMACELL-C DISPOSABLE SET (CODE 4R2256, LOT FA25E28068) - ANTICOAGULANT SODIUM CITRATE SOLUTION, USP (CODE C6B7801, LOT 24EG04019) - PLASMALINK POOLING BOTTLE (CODE 6R2069, LOT FA25D30083) * ANTISEPTIC, SALINE AND NEEDLE USED WERE NON-FRESENIUS KABI PRODUCTS. THE SAMPLES OF THE PLASMACELL-C DISPOSABLE SET, ANTICOAGULANT SODIUM CITRATE SOLUTION, USP AND PLASMALINK POOLING BOTTLE USED FOR THE SPECIFIED DONATION HAVE NOT BEEN RETURNED FOR INVESTIGATION. NO SIMILAR COMPLAINTS/RELATED ADVERSE EVENTS RECEIVED BY THE FABRICATORS OF THE PLASMACELL-C DISPOSABLE SET, PLASMALINK POOLING BOTTLE (HAINA), AND ANTICOAGULANT SODIUM CITRATE SOLUTION, USP (FRESENIUS MEDICAL CARE). THE PLASMAPHERESIS DEVICE WAS PLACED ON HOLD FOR EVALUATION. ON 29 OCTOBER 2025, A FRESENIUS KABI TECHNICIAN EXAMINED THE DEVICE ON SITE, VERIFIED ALL FUNCTIONS AND OPERATIONS AS PER THE TECHNICAL PERFORMANCE AND DIAGNOSTIC SERVICE (TPDS) CHECKLIST WITH NO ISSUES IDENTIFIED, AND DOWNLOADED THE DEVICE HISTORY LOGS. NO DEVICE ANOMALIES WERE IDENTIFIED. DETAILED LOG FILE ANALYSIS FOR THE DAY OF DONATION CONFIRMED PROPER SYSTEM PERFORMANCE, WITH ALL SAFETY AND PRESSURE ALARMS FUNCTIONING AS INTENDED. (B)(6) IS RESPONSIBLE FOR MAINTAINING PREVENTIVE MAINTENANCE AND SERVICE DOCUMENTATION FOR THEIR INSTRUMENTS. FRESENIUS KABI DOES NOT RETAIN PRIOR SERVICE HISTORY FOR THIS SERIAL NUMBER BEYOND THE TPDS AND LOG FILE EXPORT PERFORMED ON OCTOBER 29, 2025. WEIGH SCALE VERIFICATION RECORDS INDICATE DAILY CHECKS PASSED FROM SEPTEMBER 15 THROUGH OCTOBER 29 2025. SIX OF FORTY-FOUR DAYS SHOWED INITIAL READINGS DEVIATING BY NO MORE THAN +3 G FROM THE ACCEPTABLE RANGE, ALL CORRECTED UPON RECHECK. REVIEW OF THE HISTORY LOGS DETERMINED THERE WERE FIVE (5) PROCEDURES PERFORMED ON THE DATE IN QUESTION, AND IN ALL 5 PROCEDURES, THERE WAS NO INDICATION OF ANY ANOMALIES OR DEVICE MALFUNCTION. THE FIRST 4 PROCEDURES WERE UNREMARKABLE; HOWEVER, THE FINAL PROCEDURE OF THE DAY WAS TERMINATED WITH SEVERAL VEIN OCCLUSIONS DURING BOTH DRAW AND RETURN. BASED ON ADDITIONAL INFORMATION SUBSEQUENTLY RECEIVED FROM GRIFOLS, IT WAS CONFIRMED THAT THE ADVERSE EVENT OCCURRED DURING THIS FINAL PROCEDURE. REVIEW OF THE LOG FOR THIS 5TH PROCEDURE DETERMINED THE TOTAL TIME WAS 47.5 MINUTES, WITH 4 COMPLETED CYCLES AND 1 INCOMPLETE CYCLE. 10/500ML SALINE WAS USED FOR PRIMING AND 107ML OF ANTICOAGULANT (6:100 RATIO) WAS INFUSED. 1606ML OF WHOLE BLOOD WAS PROCESSED WITH 586/933ML PLASMA WITH ANTICOAGULANT COLLECTED. MULTIPLE OCCLUSION ALERTS WERE RECORDED DURING THE PROCEDURE: TWO DRAW OCCLUSION ALERTS [3508] IN CYCLES 3 AND 5, TWO RETURN OCCLUSION ALERTS [3602] IN CYCLE 1, AND ONE RETURN OCCLUSION ALERT [3603] IN CYCLE 5. OCCLUSIONS WERE DETECTED AT INTENDED PRESSURES, AND FLOW APPROPRIATELY STOPPED EACH TIME. FLOW RATES WERE ADJUSTED THROUGHOUT THE PROCEDURE IN RESPONSE TO OR ANTICIPATION OF OCCLUSIONS. THE DRAW RATE WAS REDUCED FROM 90 TO 60 ML/MIN WITHIN THE FIRST MINUTE AND SUBSEQUENTLY VARIED BETWEEN 40-80 ML/MIN. THE RETURN RATE RANGED FROM 70-100 ML/MIN. P2 (TRANSMEMBRANE) PRESSURES WERE VARIABLE BUT NOT ATYPICAL GIVEN THE FLOW CHANGES. P3 (CUFF) PRESSURE DEMONSTRATED A TRANSIENT ELEVATION AT THE END OF CYCLE 1, LIKELY RELATED TO CUFF INFLATION TO CHECK NEEDLE POSITION. THE WEIGHT SCALE, HEMOGLOBIN DETECTOR, AND RESERVOIR SENSORS SHOWED NORMAL SIGNAL PATTERNS. THE AURORA INSTRUMENT FUNCTIONED AS INTENDED, AND NO PROCEDURAL DEVIATIONS, DEVICE MALFUNCTIONS, OR MATERIAL DEFECTS WERE IDENTIFIED THAT WOULD BE EXPECTED TO CONTRIBUTE TO THE DONOR'S COLLAPSE. IN THE ABSENCE OF MEDICAL AND POST-MORTEM FINDINGS, THE RELATIONSHIP BETWEEN THE PLASMAPHERESIS PROCEDURE AND THE DONOR'S DEATH CANNOT BE DETERMINED. THE INVESTIGATION DETERMINED THAT THERE WAS NO INDICATION OF DEVICE MALFUNCTION, AND NO EVIDENCE THE DEVICE CONTRIBUTED TO THE ADVERSE EVENT. THE AURORA DEVICE IS PROGRAMMED TO MONITOR INPUTS AND TRIGGER ALERTS WHICH PAUSE THE DONATION PROCEDURE WHEN DETECTED VALUES EXCEED PROGRAMMED RANGES, REQUIRING OPERATOR ACKNOWLEDGMENT AND/OR INTERVENTION. ADDITIONAL GUIDANCE ON HOW TO ADDRESS ALARMS IS ALSO PRESENTED IN THE DEVICE'S INSTRUCTIONS FOR USE (IFU). A BATCH HISTORY REVIEW WAS COMPLETED BY THE FABRICATOR FOR THE 250ML ANTICOAGULANT SODIUM CITRATE, LOT 24EG04019, AND NO DEVIATIONS OR OUT OF SPECIFICATION RESULTS WERE REPORTED DURING THE MANUFACTURING PROCESS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE, AND THERE HAVE BEEN NO SIMILAR COMPLAINTS RECEIVED FOR THE LOT SINCE ITS RELEASE, OR FOR THE PRODUCT. THE FABRICATOR CONFIRMED THAT INTERNAL CONTROLS HAVE BEEN ESTABLISHED TO ENSURE SAFETY AND QUALITY OF ITS PRODUCTS BY SUBJECTING ALL MANUFACTURED LOTS TO A STERILIZATION PROCESS INSIDE OF HIGH TEMPERATURE VESSELS, AND AT THE SAME TIME, PHYSICOCHEMICAL, MICROBIOLOGICAL AND STERILITY TESTS ARE PERFORMED TO THE PRODUCT TO ENSURE COMPLIANCE WITH ESTABLISHED SPECIFICATIONS AND SAFETY LEVELS. THE INVESTIGATION DID NOT IDENTIFY ANY LINK TO THE REPORTED ADVERSE EVENT. THE BATCH RECORD REVIEW FOR PLASMACELL-C DISPOSABLE SET, LOT FA25E28068 AND PLASMALINK POOLING BOTTLE, LOT FA25D30083 PERFORMED BY THE FABRICATOR FOUND NO EXCEPTIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. THE LOTS MET ALL TESTING CRITERIA, INCLUDING IN PROCESS CHECKS AND POST STERILIZATION SAMPLING INSPECTION. THE INVESTIGATION ALSO FOUND NO ADVERSE COMPLAINT TREND, AND NO SIMILAR COMPLAINTS OF ANY KIND. THERE WAS NO EVIDENCE OF ANY LINK TO THE REPORTED ADVERSE EVENT. THE DEVICE AND DISPOSABLE COMPONENTS PERFORMED AS INTENDED. THE CAUSAL RELATIONSHIP BETWEEN THE PLASMAPHERESIS PROCEDURE AND THE DONOR FATALITY REMAINS INCONCLUSIVE. IN THE ABSENCE OF MEDICAL AND POST-MORTEM FINDINGS, THE RELATIONSHIP BETWEEN THE PLASMAPHERESIS PROCEDURE AND THE DONOR'S DEATH CANNOT BE DETERMINED. DONOR AGE: 22 DONOR GENDER: FEMALE DONOR HEIGHT (CM): 165 DONOR WEIGHT (KG): 110 SCREENING BLOOD PRESSURE: 125/74 SCREENING PULSE: 76 SCREENING HCT: 38.80% SCREENING TOTAL PROTEIN: 7.70G/DL GRIFOLS REPORTED THAT THE DONOR SHOWED NO ADVERSE SIGNS OR SYMPTOMS PRIOR TO THE LOSS OF CONSCIOUSNESS, AND THE SELF-COMPLETED DONOR QUESTIONNAIRE DID NOT DISCLOSE ANY MEDICAL CONDITIONS, MEDICATIONS, SURGERIES, ALLERGIES OR ANY OTHER INFORMATION WHICH WOULD HAVE DISQUALIFIED DONATION. NO FURTHER MEDICAL INFORMATION IS AVAILABLE AT THIS TIME, INCLUDING THE OFFICIAL CAUSE OF DEATH. NO FURTHER MEDICAL INFORMATION IS AVAILABLE AT THIS TIME, INCLUDING THE OFFICIAL CAUSE OF DEATH. PLEASE NOTE, THIS EVENT OCCURRED IN CANADA. MEDICAL RECORDS AND AUTOPSY REPORTS HAVE NOT BEEN MADE AVAILALE TO FRESENIUS KABI CANADA. PROVISIONAL PRIVACY LAWS PRECLUDE FRESNIUS KABI FROM OBTAINING THIS INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2361607 | FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM | FOR COLLECTION OF VIRTUALLY CELL FREE PLASMA BY MEMBRANE FILTRATION. FOR USE WIT | GKT | FENWAL INTERNATIONAL INC. | 4R2256 | FA25E28068 | 04086000101356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |