Fenwal PLASMACELL-C Disposable Set For Use With SPIKESMART System 4R2256Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04086000101356), received between Sep 28, 2023 and Nov 24, 2025 — classified as 1 death, 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 D

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23633921 ↗
• InjurySep 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FRESENIUS KABI CANADA REPORTED AN INCIDENCE OF HEMOLYTIC PLASMA DURING A DONATION ON THE AURORA PLASMAPHERESIS SYSTEM. THE DONOR EXPERIENCED SYMPTOMS OF HEMOLYSIS SUCH AS FLANK PAIN, DISCOLORED URINE AND KIDNEY-RELATED COMPLICATIONS THAT REQUIRED A 10-DAY HOSPITALIZATION. SAMPLES HAVE BEEN RETURNED FOR EVALUATION AND THE DEVICE LOG FILES ARE BEING REVIEWED. A FOLLOW-UP MDR WILL BE FILED ONCE THE INVESTIGATION OF THIS EVENT IS COMPLETE.

  Patient problems: Hematuria; Hemolysis; Renal Impairment

  MAUDE report 17837176 ↗