PLASMACELL Xi Disposable Set with SPIKESMART 6R2600PRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00810020441116), received between Oct 14, 2024 and Sep 28, 2026 — classified as 5 deaths, 2 injuries, 1 malfunction.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• OtherSep 28, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Hematuria

  MAUDE report 50920795 ↗
• DeathSep 28, 2026Appropriate Device Problem Term/Code Not Available

  An email from BioMat Phenix City on September 4, 2026 stated they are investigating a donor fatality. The donor was a qualified 55-year-old male that presented for a routine donation on (b)(6) 2026 and completed an uncomplicated donation which began at 07:29 AM and ended at 08:08 AM. The donor donated 627 mL of plasma with a total collection volume of 704 mL. There were no collection exceptions or unusual events noted during his donation. The donor had no adverse events during the donation. The donor center was informed by a neighbor of the donor that he died on (b)(6) 2026. Information received from the local coroner indicated that the donor was home working in the garden after he donated when he developed chest pain and requested Pepto-Bismol from a neighbor. He collapsed at the neighbor's home, EMS was contacted and they attempted to resuscitate him. However, EMS was never able to obtain a pulse and the donor was pronounced deceased at 12:03 PM. The donor had reported a diagnosis of hypertension for which he had been prescribed losartan. No autopsy was performed. Toxicology samples were collected and expected to take several months for results. The coroner did indicate that a fa

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

  MAUDE report 50920792 ↗
• MalfunctionMar 31, 2026Appropriate Device Problem Term/Code Not Available

  THE DONOR IS A 55-YEAR-OLD FEMALE DONOR WITH A LONG HISTORY OF SUCCESSFULLY DONATING PLASMA AT THE CENTER ((B)(6) LIFETIME PLASMA COLLECTIONS IN THE CURRENT BLOOD ESTABLISHMENT COMPUTER SYSTEM WITH NO PREVIOUSLY DOCUMENTED DONOR ADVERSE EVENTS) WHO PRESENTED FOR A ROUTINE DONATION ON (B)(6) 2026. THE ONLY MEDICAL CONDITION THE DONOR HAD REPORTED WAS HYPERTENSION FOR WHICH SHE WAS PRESCRIBED LOSARTAN. THE DONOR MET ALL DONOR ELIGIBILITY REQUIREMENTS AND THE DONATION BEGAN AT 9:17AM FOLLOWING A SUCCESSFUL VENIPUNCTURE IN THE LEFT ARM. DURING DRAW CYCLE #3 THE DONOR BEGAN FEELING UNWELL AND LOST CONSCIOUSNESS. EMS WAS CONTACTED AND THE DONOR WAS TRANSPORTED TO THE LOCAL HOSPITAL FOR EVALUATION. THE PROCEDURE TARGETED A PLASMA COLLECTION VOLUME OF 885 ML; HOWEVER, THE FINAL PLASMA YIELD WAS 292 ML. A TOTAL OF 899 ML OF WHOLE BLOOD WAS PROCESSED DURING THE PROCEDURE. THE DONATION WAS TERMINATED DURING RETURN 3 WITHOUT COMPLETION OF A FULL FLUID RETURN. NO PROCEDURAL SALINE WAS ADMINISTERED BEYOND PRIMING VOLUME. A TOTAL OF 39 ML OF SODIUM CITRATE ANTICOAGULANT WAS REPORTEDLY USED DURING THE PROCEDURE. THE DONATION WAS TERMINATED EARLY DUE TO THE DONOR'S SYMPTOMS WHICH RESULTED IN A RBC

  Patient problems: Loss of consciousness

  MAUDE report 24745142 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  THE DONOR IS A 30-YEAR-OLD QUALIFIED MALE DONOR WHO COMPLETED A NON-COMPLICATED DONATION ON (B)(6) 2026. THE DONOR THEN RETURNED ON (B)(6) 2026 TO COMPLETE ANOTHER ROUTINE DONATION AND JUST PRIOR TO STARTING THE DONATION PROCESS, INFORMED A PHLEBOTOMIST THAT HE HAD RECENTLY BEEN DISCHARGED FROM THE HOSPITAL AFTER EXPERIENCING AN ACUTE STROKE. THE DONOR WAS NOT PERMITTED TO DONATE ON (B)(6) 2026. CENTER MEDICAL STAFF INTERVIEWED THE DONOR ON (B)(6) 2026, AND HE REPORTED THAT SOMETIME AFTER HIS DONATION ON (B)(6) 2026, HE EXPERIENCED LOSS OF CONSCIOUSNESS, SLURRED SPEECH, FACIAL DROOP, AND LEFT SIDED PARALYSIS. THIS MAY HAVE STARTED AFTER HE SMOKED A CIGARETTE. HE WAS APPARENTLY HOSPITALIZED FOR AN UNKNOWN NUMBER OF DAYS, AND ALL OF HIS SYMPTOMS WERE RESOLVED. HE DID NOT REPORT WHAT TREATMENT HE RECEIVED AND HAD DENIED TAKING ANY MEDICATIONS DURING HIS VISIT ON (B)(6) 2026. UPON REVIEW OF THE DONOR'S DONATION RECORD, HE HAS NEVER REPORTED ANY MEDICAL CONDITIONS OR MEDICATIONS. HE HAS NO HISTORY OF ADVERSE EVENTS ASSOCIATED WITH DONATION AND DEFERRAL TRENDS. NO HOSPITAL MEDICAL RECORDS, DIAGNOSTIC IMAGING, LABORATORY DATA, OR DISCHARGE SUMMARIES HAVE BEEN PROVIDED TO INDEPENDENTLY CON

  Patient problems: Stroke/CVA

  MAUDE report 24431034 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO KIT SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. THEREFORE, THE CUSTOMER REPORTED COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE IDENTIFIED. THE FOLLOWING CURRENT CONTROLS ARE IN PLACE TO ASSURE INTEGRITY OF THE KIT 1) IN PROCESS SAMPLING QUALITY INSPECTION AND 2) POST STERILIZATION SAMPLING FINAL INSPECTION. THE BATCH RECORD FOR BATCH FA25C21035, MATERIAL 6R2600P WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. THE FSE (FIELD SERVICE ENGINEER) STATED THE TPDS (TEST PROCEDURE DATA SHEET) WAS COMPLETED. THE FSE STATED THAT THE DEVICE PASSED ALL TESTING AFTER THE PART WAS REPLACED. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. A DEVICE HISTORY REVIEW OF THE DEVICE SERIAL NUMBER (B)(6) WAS CONDUCTED IN ORDER TO IDENTIFY POTENTIAL RELATED MANUFACTURING NON-CONFORMANCES. THE REVIEW YIELDED NO NON-CONFORMANCES RELATED TO THIS ISSUE. A REVIEW OF THE SERVICE RECORDS FOR THIS DEVICE, SERIAL NUMBER (B)(6) FOUND NO SAME/SIMILAR COMPLAINTS RELATED TO THIS ONE. A SEARCH OF CAPAS FOUND N

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

  MAUDE report 22924100 ↗
• DeathJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT ON (B)(6) 2025, BIOLIFE PLASMA SERVICES RECEIVED NOTIFICATION OF A DONOR'S DEATH. A BIOLIFE CENTER EMPLOYEE REPORTED VIEWING A SOCIAL MEDIA POST ABOUT THE DEATH, ALTHOUGH THE EMPLOYEE WAS NOT DIRECTLY AFFILIATED WITH THE DONOR. BIOLIFE MEDICAL AFFAIRS COORDINATED A RECORDS REVIEW WITH REGULATORY AFFAIRS AND QUALITY OPERATIONS WHICH CONFIRMED THAT THE DONOR HAD LAST DONATED ON (B)(6) 2025, THAT A PUBLICLY AVAILABLE OBITUARY STATED THE DEATH OCCURRED AT 15:55 ON (B)(6) 2025 AND THAT THE FATALITY HAD NOT BEEN PREVIOUSLY REPORTED TO BIOLIFE. THE BIOLIFE CENTER PHYSICIAN CONTACTED THE MEDICAL EXAMINER'S OFFICE ON (B)(6) 2025 AND THE CAUSE OF DEATH WAS NOT PROVIDED. THIS 31-YEAR-OLD MAN HAD A TOTAL OF 183 DONATIONS BEGINNING ON (B)(6) 2013 WITH 64 DONATIONS IN THE PAST 24 MONTHS. THE DONOR UNDERWENT THE STANDARD APPLICANT DONOR PROCESS: ELECTRONIC DONOR HISTORY QUESTIONNAIRE (EDQ), PHYSICAL EXAMINATION, EDUCATION AND CONSENT, DONOR SCREENING (VITAL SIGNS, HEMATOCRIT AND PROTEIN DETERMINATION), DONOR PHLEBOTOMY WITH COLLECTION OF ALL LABORATORY TESTING SAMPLES INCLUDING THOSE FOR STS AND SERUM PROTEIN ELECTROPHORESIS (SPE). THE DONOR RECORD INDICATED NO MEDICATI

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

  MAUDE report 22329087 ↗
• DeathMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 BIOLIFE PLASMA SERVICES RECEIVED TELEPHONE NOTIFICATION OF A DONOR DEATH. THE CHIEF MEDICAL EXAMINER IN (B)(6) NOTED THE DONOR HAD DIED AT HIS HOME ON (B)(6) 2024. THE CHIEF MEDICAL EXAMINER RELATED THAT NO CAUSE OF DEATH WAS KNOWN AND INITIATED A REQUEST FOR BIOLIFE RECORDS. A REVIEW OF DONOR RECORDS SHOWS THE DONOR LAST DONATED ON (B)(6) 2024. THE BIOLIFE CENTER PHYSICIAN CONTACTED THE MEDICAL EXAMINER'S OFFICE ON (B)(6) 2025 AND WAS INFORMED THAT WHILE THE CAUSE OF DEATH IS NOT KNOWN THAT A HISTORY OF NAUSEA, VOMITING AND CEPHALGIA WERE NOTED AFTER PLASMAPHERESIS AND THAT UNSPECIFIED HYPONATREMIA WAS ALSO NOTED. UPON NOTIFICATION OF THE DONOR'S DEATH, THE PLASMAPHERESIS DEVICE WAS TAKEN OUT OF SERVICE. THE PLASMAPHERESIS DEVICE LOGS AND SINGLE USE COLLECTIONS MATERIALS RECORDS WERE INSPECTED AND NO ABERRANT FINDINGS WERE NOTED. THE PREVENTATIVE MAINTENANCE TPDS WAS PERFORMED ON (B)(6) 2025 AND FOUND THE INSTRUMENT TO BE WORKING AS INTENDED. IN CONCLUSION, THE DEATH OF THE DONOR, OCCURRING SHORTLY AFTER A PLASMA DONATION AT BIOLIFE PLASMA SERVICES, THE REPORTED SYMPTOMS OF NAUSEA, VOMITING, CEPHALGIA, AND UNSPECIFIED HYPONATREMIA NOTED BY THE MEDICAL EXAMINER. HOWE

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

  MAUDE report 22044025 ↗
• DeathMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DONOR WAS A 22-YEAR-OLD MALE WHO COMPLETED AN UNCOMPLICATED DONATION ON (B)(6) 2025. THE CENTER WAS NOTIFIED ON 04/09/2025 BY THE DONOR'S HEALTHCARE PROVIDER THAT THE DONOR HAD DIED ON (B)(6) 2025. THE DONOR HAD DONATED TWO TIMES AT THE DONOR CENTER SINCE HIS FIRST DONATION ON (B)(6) 2025. REVIEW OF THE ELECTRONIC RECORDS FROM THE DONOR'S TWO DONATIONS, INCLUDING THE DONOR'S NEW APPLICANT DONOR ELIGIBILITY ASSESSMENT FROM (B)(6) 2025, REVEALED THAT THE ONLY MEDICAL CONDITION REPORTED BY THE DONOR WAS ANXIETY FOR WHICH HE HAD BEEN PRESCRIBED CLONAZEPAM TO USE AS NEEDED. HE REPORTED NO OTHER MEDICAL CONDITIONS, MEDICATIONS, OR ALLERGIES. THE HANDS-ON PHYSICAL EXAM FROM THIS DATE WAS UNREMARKABLE OTHER THAN AN ABDOMINAL SCAR FROM A REPORTED APPENDIX REMOVAL IN 2015. THE DONOR COMPLETED SUCCESSFUL DONATIONS (B)(6) 2025 AND (B)(6) 2025 WITH NO ASSOCIATED DONOR ADVERSE EVENTS OR RBC LOSSES. THE DONOR ATTEMPTED A DONATION ON (B)(6) 2025 BUT WAS DEFERRED DUE TO AN UNACCEPTED SCREENING PULSE READING OF 101. A SERUM PROTEIN ELECTROPHORESIS COLLECTED ON (B)(6) 2025 WAS ACCEPTABLE. THE DONATION ON (B)(6) 2025 BEGAN AT 11:31 AM FOLLOWING A SUCCESSFUL VENIPUNCTURE IN THE RIGHT ARM. THE TOTAL

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

  MAUDE report 21993679 ↗
• DeathOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DONOR WAS A 46-YEAR-OLD MALE THAT HAS 143 DONATIONS AVAILABLE FOR REVIEW IN THE CURRENT BECS SYSTEM DATING BACK TO (B)(6) 2023. THE DONOR HAS ALSO DONATED AT THIS CENTER PRIOR TO (B)(6) 2023 WITH DONATION DATA IN A SEPARATE BECS SYSTEM DATA BASED. REVIEW OF THE DONORS' DONATIONS BACK TO (B)(6) 2023 INCLUDING THE DONOR'S MOST RECENT ANNUAL DONOR ELIGIBILITY ASSESSMENT FROM (B)(6) 2023 REVEALED NO DONOR REPORTED MEDICAL CONDITIONS, MEDICATIONS, OR ALLERGIES. THE PHYSICAL EXAM FROM THIS DATE WAS UNREMARKABLE. DURING THIS TIME FRAME NO DONOR ADVERSE EVENTS WERE DOCUMENTED AND THE DONOR WAS DEFERRED ONE TIME ON (B)(6) 2023 FOR A LESS THAN 200 ML RBC LOSS. NO DEFERRAL TRENDS WERE NOTED ALTHOUGH THE DONOR DID REQUIRE A REPEAT VENIPUNCTURE SEVERAL TIMES DURING THIS DONATION TIME FRAME. THE MOST RECENT SPE WAS COLLECTED ON (B)(6) 2024 AND WAS ACCEPTABLE. THE DONATION BEGAN AT 10:03 AM FOLLOWING A SUCCESSFUL VENIPUNCTURE IN THE LEFT ARM. THE TOTAL COLLECTION VOLUME WAS 897ML AND THE PLASMA COLLECTION VOLUME WAS 801ML. THE DONOR RECEIVED 500ML OF PROCEDURAL SALINE. NO APHERESIS COMPLICATIONS OR DONOR ADVERSE EVENTS WERE NOTED DURING OR AFTER THE DONATION. CENTER MANAGEMENT REVIEWED THE VI

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

  MAUDE report 20441362 ↗