Spectra Optia® 12320Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 05020583123205), received between Sep 7, 2018 and Aug 25, 2026 — classified as 2 deaths, 60 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (64 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 119 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Insufficient Device Problem Information

  Customer reported that after a Continuous Mononuclear Cell Collection (CMNC) the patient's hematocrit dropped from 37% to 25% requiring 2 untis of blood.  Per customer patient outcome "Stable before and after procedure. Discharged." The Collection set is not available for return because it was discarded by the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436013 ↗
• InjuryAug 14, 2026Insufficient Device Problem Information

  The customer reported during the red blood cell depletion of allogeneic bone marrow, an incident occurred involving the OPTIA kit required to perform this type of processing. Specifically, the machine displayed the error message "Overpressure at the ring", and a leak was observed by the operator. The patient was given Prophylactic antibiotic therapy. Due to EU personal data protection laws, the patient information is not available from the customer.

  Patient problems: Insufficient Information

  MAUDE report 50254978 ↗
• MalfunctionAug 10, 2026Insufficient Device Problem Information

  Customer reported that the product had Staphylococcus epidermidis in all 4 cultures taken after collection. The Collection set is not available for return because it was discarded by the customer.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195273 ↗
• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED HYPOCALCEMIA THAT REQUIRED AN INTRAVENOUS SUBSTITUTION OF IONIZED CA < 1.0 MMOL/L. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. TERUMO BCT IS AWAITING RETURN OF THE COLLECTION SET FOR EVALUATION.

  Patient problems: Cramp(s) /Muscle Spasm(s); Hypocalcemia

  MAUDE report 25845794 ↗
• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED HYPOCALCEMIA ACCOMPANIED BY TETANY THAT REQUIRED AN INTRAVENOUS SUBSTITUTION OF IONIZED CA < 1.0 MMOL/L. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. TERUMO BCT IS AWAITING RETURN OF THE COLLECTION SET FOR EVALUATION.

  Patient problems: Cramp(s) /Muscle Spasm(s); Hypocalcemia

  MAUDE report 25845678 ↗
• MalfunctionMay 11, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED DURING PRIMING CUSTOMIZED WITH BLOOD BAG FOR A STEM CELL COLLECTION THERE WAS A PRESENCE OF AIR IN THE RETURN LINE. THE ALARM PREVENTED CONTINUATION, SO THE SET WAS REPLACED AND THERE WERE NO FURTHER ISSUES NOTED. PER THE CUSTOMER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REQUIRED FOR THIS EVENT AND THE PATIENT WAS CLINICALLY STABLE. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. PATIENT INFORMATION IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142688 ↗
• MalfunctionJan 12, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  BONE MARROW PROCESSING WAS PERFORMED ON THE OPTIA ACCORDING TO THE USUAL PROCEDURE AT THE CUSTOMER SITE, BUT WITH TECHNICAL DIFFICULTIES, AS THE PRODUCT OBTAINED WAS EXCESSIVELY HEMATIC DESPITE INCREASING THE COLLECTION PREFERENCE, AND WITH SIGNIFICANT INTERFACE INSTABILITY AND UNUSUAL IMAGES, DESPITE CORRECT ANTICOAGULATION OF THE PRODUCT. FLOW CYTOMETRY ON THE BONE MARROW BAG AFTER PROCESSING (I.E., ON THE LEFTOVER PRODUCT), AND ONLY 0.3 × 106 CD34/KG REMAINED. THE CYTOMETRIST REPORTED SEEING A LARGE AMOUNT OF CELLULAR DEBRIS. SUBSEQUENTLY, THEY CENTRIFUGED THIS EXCESS, AND OBSERVED VERY SIGNIFICANT HEMOLYSIS, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTY IN PROPERLY ADJUSTING THE INTERFACE. PATIENT ID, AGE, GENDER AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038317 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED WHILE RUNNING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROCEDURE ON A PATIENT WITH MELANOMA THEY HAD ISSUES WITH PERIPHERAL ACCESS LOSS FROM THE PATIENT MOVING AND HAD TO PUT IN ANOTHER NEEDED FOR THE DRAW. THE PATIENT BECAME UNRESPONSIVE WITH AGONAL BREATHING. THE RAPID RESPONSE PHYSICIAN AT THE SITE PROCEEDED TO INTUBATE THE PATIENT. THE CUSTOMER ALSO INDICATED THAT UNPLANNED "VENKIMAISEN" WAS PROVIDED TO THE PATIENT. PER THE CUSTOMER, PRIOR TO THE PROCEDURE, THE PATIENT WAS DEHYDRATED AND EXPERIENCED VOMITING AND NAUSEA FOR THE 2 PRIOR DAYS. THE PATIENT DID WALK INTO THE CLINIC WITH A BLOOD PRESSURE (BP) OF 109/65 AND WHEN THEY LOST ACCESS IT WAS 140/77. THE PATIENT WAS GIVEN A NORMAL SALINE BOLUS PRIOR TO STARTING THE PROCEDURE. FULL PATIENT ID: (B)(6) PER THE CUSTOMER, THE PATIENT IS CURRENTLY WEANING OFF INTUBATION IN THE ICU.

  Patient problems: Hyperventilation; Loss of consciousness

  MAUDE report 23805191 ↗
• MalfunctionAug 25, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "COMPARISON OF TWO LEUKOCYTAPHERESIS PROTOCOLS IN A CASE OF IDIOPATHIC HYPEREOSINOPHILIC SYNDROME" BY MICHAEL L. WANG, ROBERTSON D. DAVENPORT, AND CHISA YAMADA BACKGROUND: HYPEREOSINOPHILIC SYNDROME (HEOS) IS RARE, AND THE EFFICACY OF LEUKOCYTAPHERESIS IN THIS CONTEXT IS UNCLEAR. WE HERE REPORT THE SUCCESSFUL TREATMENT OF A PATIENT WITH IDIOPATHIC HEOS WITH FOUR LEUKOCYTAPHERESIS PROCEDURES USING TWO PROTOCOLS. CASE: A 4-YEAR-OLD FEMALE PRESENTED WITH CARDIAC AND RESPIRATORY DYSFUNCTION, AND WBC OF 225 K/LL WITH 96% EOSINOPHILS. LEUKOCYTAPHERESIS WAS STARTED AFTER INITIATION OF METHYLPREDNISOLONE AND HYDROXYUREA. SHE RECEIVED TWO LEUKOCYTAPHERESIS WITH POLYMORPHONUCLEAR CELL (PMN) PROTOCOL, FOLLOWED BY INITIATION OF IMATINIB THERAPY, THEN TWO LEUKOCYTAPHERESIS WITH MONONUCLEAR CELL (MNC) PROTOCOL. AFTER THE FOURTH LEUKOCYTAPHERESIS, HER WBC DECREASED TO 69 K/LL WITH 82% EOSINOPHILS. SHE WAS DISCHARGED ON HOSPITAL DAY 21 UNDER STABLE CONDITION WITH WBC OF 22 K/LL WITH 86% EOSINOPHILS. WBC COUNT AND EOSINOPHIL PERCENTAGE CONTINUED TO DECREASE, AND WERE 6.4 K/LL AND 52% BY 2 WEEKS AND 3.9 K/LL AND 4.9% BY 3 MONTHS AFTER DISCHARGE, RESPECTIVELY. FINDINGS: WBC AND AB

  Patient problems: Dehydration; Headache; No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 22885178 ↗
• DeathAug 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "COMPARING LEUKAPHERESIS PROTOCOLS FOR AN AML PATIENT WITH SYMPTOMATIC LEUKOSTASIS. JOURNAL OF CLINICAL APHERESIS" BY CLINE, A., JAJOSKY, R., SHIKLE, J., & BOLLAG, R. BACKGROUND: ACUTE MYELOID LEUKEMIA (AML) IS A MALIGNANCY CHARACTERIZED BY RAPID CLONAL PROLIFERATION OF MYELOID PRECURSORS, WHICH CAN RESULT IN HYPERLEUKOCYTOSIS. LEUKAPHERESIS CAN BE USED TO RAPIDLY REDUCE THE WHITE BLOOD CELL COUNT (WBC). HOWEVER, THE ONLY FDA CLEARED DEVICE FOR WBC DEPLETION, THE COBE SPECTRA, WILL NO LONGER BE SUPPORTED BY THE MANUFACTURER IN 2017, AND THERE ARE FEW STUDIES COMPARING DIFFERENT METHODS OF LEUKAPHERESIS. CASE REPORT: A 68-YEAR-OLD AFRICAN AMERICAN FEMALE WAS ADMITTED TO THE HOSPITAL FOR RELAPSE OF HER AML. LABORATORY DATA DEMONSTRATED A WBC COUNT OF 291 600/LL AND FLOW CYTOMETRY OF THE PERIPHERAL BLOOD DEMONSTRATED 85% MYELOID BLASTS. LEUKAPHERESIS WAS ORDERED TO HELP TREAT THE LEUKOSTASIS. METHODS: THREE DIFFERENT APHERESIS PROTOCOLS WERE USED TO ACHIEVE CYTOREDUCTION: SPECTRA OPTIA MONONUCLEAR COLLECTION (MNC) PROTOCOL, SPECTRA OPTIA GRANULOCYTE COLLECTION (PMN) PROTOCOL, AND THERAKOS CELLEX BUFFY COAT COLLECTION WITHOUT RETURN. DUE TO DIFFERENT INLET FLOW RATE

  Patient problems: Fatigue; Muscle Weakness/Atrophy; Ptosis

  MAUDE report 22884441 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE ¿NURSE-LED APHERESIS SERVICE IN A PEDIATRIC RESTRUCTURED HOSPITAL: THE PAST, THE PRESENT, AND THE FUTURE¿, BY ANH, P. T. N., ZHONG, X., LIM, S. L. Y., PERIAKARUPPAN, P. W., & K, V., APHERESIS NURSES ARE WELL EQUIPPED WITH NOT ONLY THE CRITICAL THINKING SKILLS BUT ALSO THE IMPORTANT ASPECTS OF OPERATING THE APHERESIS MACHINE. AS THE DEMAND FOR ADVANCED CELLULAR THERAPIES GREW, THERE WAS A NEED TO RECRUIT AND TRAIN MORE NURSES TO BE COMPETENT IN APHERESIS NURSING. A NEW SERVICE MODEL WAS EVOLVED FROM A PHYSICIAN-LED TO A NURSE-LED APHERESIS SERVICE, WHICH EMPOWERED THE APHERESIS NURSES TO LEAD THE SERVICE. SINCE THE COMMENCEMENT OF THE NURSE-LED SERVICE, A TOTAL OF 32 PERIPHERAL HEMATOPOIETIC PROGENITOR CELLS COLLECTIONS WERE DOCUMENTED, AND THE OUTCOMES OF THE CELL YIELD WERE TABULATED TO STUDY THE COLLECTION EFFICIENCY. NINETY-FOUR PERCENT OF THE TARGETED CELL YIELD WAS ACHIEVED WITH NO COLLECTIONS NEEDING BEYOND 2 DAYS OF HARVESTING. NO APHERESIS-RELATED MAJOR ADVERSE EVENT WAS REPORTED FOLLOWING THE IMPLEMENTATION OF THE NEW SERVICE MODEL TOO. THE SERVICE UTILIZED THE SPECTRA OPTIA APHERESIS SYSTEM, AS IT WAS ASSOCIATED WITH HIGHER CELL COLLECTION EFFICIENCY,

  Patient problems: Convulsion/Seizure; Hypersensitivity/Allergic reaction; Nausea; Paresthesia; Unspecified Gastrointestinal Problem; Vomiting

  MAUDE report 21858683 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED AN ALLERGIC REACTION DURING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMN) ON SPECTRA OPTIA DEVICE, THAT THE CUSTOMER BELIEVED WAS RELATED TO ETHYLENE OXIDE (ETO). PER THE CUSTOMER, THE PATIENT BROKE OUT IN HIVES ON THEIR EARS, NECK, STOMACH, AND LEGS AND ALSO BECAME FLUSH. IT WAS REPORTED THAT THE PATIENT WAS GIVEN BENADRYL, AS WELL AS OTHER MEDICATION, AND THEN COMPLAINED OF 10/10 ABDOMINAL PAIN AND WAS TRANSPORTED TO THE HOSPITAL VIA EMERGENCY MEDICAL SERVICES (EMS). IT WAS NOTED THAT THE PATIENT DONATED 3 YEARS EARLIER WITH NO KNOWN ISSUES. THE PATIENT'S CONDITION WAS REPORTED AS "DISCHARGED HOME". THE NURSE STATED THAT THE AC INFUSION RATE WAS 0-1.2. THE PROCEDURE STARTED AT 7:52, WAS PAUSED AT 8:58, AND NO RINSEBACK WAS GIVEN. THE TYPE OF ANTICOAGULANT USED/CONCENTRATION OF SOLUTION WAS ACID-CITRATE-DEXTROSE FORMULA A (ACDA) 750 ML BAG WITH 0.9 ML HEPARIN 5000 UNIT/ML, AND ALL SOLUTIONS WERE CORRECTLY ATTACHED. THE REPORTED TOTAL AMOUNT OF AC DELIVERED WAS 278 ML, AND THE REPORTED TOTAL AMOUNT OF AC DELIVERED WAS NOT GREATER THAN WHAT WAS REPORTED BY THE DEVICE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Abdominal Pain; Hot Flashes/Flushes; Itching Sensation; Rash; Urticaria

  MAUDE report 21774173 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A PATIENT FOR A WHITE BLOOD CELL DEPLETION (WBCD) PROCEDURE ON SPECTRA OPTA PATIENT PASSED AWAY. PER THE PHYSICIAN, BEFORE THE PROCEDURE BEGAN HEMATOLOGY ONCOLOGY WAS CONSULTED WHO RECOMMENDED CONTINUING HYDROXYUREA AND STARTING LEUKOPHERESIS DUE TO CONCERN FOR LEUKOSTASIS, GIVEN THE EXTENT OF HIS LEUKOCYTOSIS. PROPHYLAXIS MEDICATIONS WERE CONTINUED, WITH THE ADDITION OF MICAFUNGIN. HYDRATION WAS ALSO CONTINUED TO HELP TREAT TUMOR LYSIS SYNDROME (TLS), WITH A FLUID BOLUS AND LASIX CHALLENGE BEING DONE, BUT THIS REPORTEDLY FAILED. THE FAILED LASIX CHALLENGE LED TO A NEPHROLOGY CONSULTATION, WHO AGREED TO PROCEED WITH HEMODIALYSIS AFTER LEUKOPHERESIS WAS COMPLETED. THE PATIENT WAS REPORTED TO HAVE A HEMODIALYSIS (HD) CATHETER PLACED AROUND 2 PM IN PREPARATION FOR LEUKOPHERESIS AND HEMODIALYSIS. LEUKOPHERESIS WAS THEN INITIATED AND HAD BEEN RUNNING FOR APPROXIMATELY AN HOUR WHEN AROUND 7:00 PM, A CODE BLUE WAS CALLED FOR BRADYCARDIA. THE PHYSICIAN STATED THAT THE PATIENT BECAME INCREASINGLY SOMNOLENT, DIFFICULT TO ROUSE AND HAD PROGRESSIVE DESATURATE AND THE DECISION WAS MADE TO INTUBATE. ADDITIONALLY, THE PATIENT APPEARED TO HAVE GRADE IIB-III AIRWAY, WITH

  Patient problems: Bradycardia; Insufficient Information; Lethargy; Low Oxygen Saturation; Sleepiness/Drowsiness/Somnolence

  MAUDE report 21619646 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A SUSPECTED LEAK IN THE CENTRIFUGE DURING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROCEDURE ON A SPECTRA OPTIA DEVICE. APPROXIMATELY ONE HOUR INTO THE PROCEDURE, THE DEVICE GENERATED A ¿LEAK DETECTED IN THE CENTRIFUGE¿ ALARM. THE ATTENDING NURSE INSPECTED THE DEVICE AND DID NOT OBSERVE VISIBLE LEAKS BUT WAS UNABLE TO PROCEED WITH THE PROCEDURE. IT WAS REPORTED THAT THE COLLECTED BLOOD VOLUME COULD NOT BE REINFUSED INTO THE PATIENT. AS A RESULT, THE NURSE DISCONNECTED THE PATIENT FROM THE DEVICE. THE PATIENT SUBSEQUENTLY DEVELOPED ANEMIA, AND THE ATTENDING PHYSICIAN ORDERED A RED BLOOD CELL (RBC) TRANSFUSION. THE PATIENT WAS REPORTED AS ¿STABLE¿. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT IDENTIFICATION AND WEIGHT ARE NOT AVAILABLE FROM THE CUSTOMER. PATIENT WEIGHT WAS OBTAINED FROM THE RUN DATA FILE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Anemia

  MAUDE report 21505363 ↗
• MalfunctionDec 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A CELLULAR THERAPY COLLECTION ON A SPECTRA OPTIA DEVICE, A POSITIVE CULTURE FOR SALMONELLA ENTERICA SSP ENTERICA WAS IDENTIFIED ON THE SECOND DAY OF COLLECTION USING BACT TESTING PROCEDURES. PER THE CUSTOMER, THE PATIENT EXHIBITED NO SYMPTOMS ON EITHER THE FIRST OR SECOND DAY OF COLLECTION. ADDITIONALLY, THE CUSTOMER COLLECTED CULTURES FROM THE PATIENT¿S LINES (TIP, RED LUMEN AND RIGHT ARM), WITH NEGATIVE RESULTS. THE PATIENT WAS REPORTED TO HAVE NO SIGNS OR SYMPTOMS OF INFECTION, SHOWED ¿NO CHANGE¿, AND NO MEDICAL INTERVENTION WAS REPORTED. FULL PATIENT UNIT ID: (B)(6) THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914667 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT FOLLOWING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROCEDURE A PATIENT PASSED OUT AFTER GETTING UP. PER THE CUSTOMER THEY HAD A LOW HCT POST PROCEDURE AND LOW PLT COUNT. DURING THE PROCEDURE THEY RECEIVED ALARMS FOR AIR IN RETURN LINE AND RESERVOIR FULL DURING AIR REMOVAL ALARM. THERE WAS NO AIR IN THE RETURN LINE SEEN BUT THEY WERE NOT ABLE TO CONTINUE WITH PROCEDURE. NO RINSE BACK WAS COMPLETED. PER THE CUSTOMER 2 UNITS OF PRBC 1 UNIT OF PLTS WAS GIVEN AND THE PATIENT IS IN STABLE CONDITION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Syncope/Fainting

  MAUDE report 20559880 ↗
• MalfunctionSep 17, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A BACTERIAL CONTAMINATION (GRAM POSITIVE COCCI) IN PRODUCT COLLECTED DURING A CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION PROCEDURE. FULL PATIENT ID: (B)(6) PER CUSTOMER PATIENT WAS RELEASED TO SELF WITH NO MEDICAL INTERVENTION REQUIRED THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236796 ↗
• MalfunctionSep 10, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A POSSIBLE CONTAMINATION ISSUE DURING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) ON A SPECTRA OPTIA DEVICE. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184437 ↗
• MalfunctionSep 10, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A POSSIBLE CONTAMINATION ISSUE DURING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) ON A SPECTRA OPTIA DEVICE. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184413 ↗
• InjurySep 3, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE ""THERAPEUTIC WHITE BLOOD CELL AND PLATELET DEPLETIONS USING THE SPECTRA OPTIA SYSTEM CONTINUOUS MONONUCLEAR CELL PROTOCOL"". BY NANCY C. CATES, , DARLENE J. OAKLEY, , OLUWATOYOSI A. ONWUEMENE, ABSTRACT THE SPECTRA OPTIA APHERESIS SYSTEM® HAS ONLY RECENTLY BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION (FDA) FOR THERAPEUTIC WHITE BLOOD CELL (WBC) AND IS NOT YET APPROVED FOR PLATELET DEPLETIONS. PRIOR TO FDA-APPROVAL OF THE WBC DEPLETION PROTOCOL, WHEN OUR AVAILABLE COBE SPECTRA APHERESIS SYSTEMS WERE OUT OF SERVICE, WE SUCCESSFULLY PERFORMED WBC DEPLETION USING A MODIFIED SPECTRA OPTIA APHERESIS SYSTEM CONTINUOUS MONONUCLEAR CELL (CMNC) PROTOCOL. USING THIS MODIFIED SPECTRA OPTIA CMNC PROTOCOL, WE CREATED INSTITUTIONAL PROTOCOLS FOR WBC AND PLATELET DEPLETIONS. WE PERFORMED 10 WBC DEPLETIONS IN 9 PATIENTS AND 2 PLATELET DEPLETIONS IN 2 PATIENTS. WE COMPARED PRE- AND POST-PROCEDURE WBC, PLATELET COUNT, AND HEMOGLOBIN TO THE SAME DATA FROM PATIENTS PREVIOUSLY TREATED ON THE COBE SPECTRA AND FOUND NO DIFFERENCE IN % WBC AND PLATELET REDUCTION. WE ALSO FOUND NO SIGNIFICANT DIFFERENCE IN POST-PROCEDURAL HEMATOCRIT DECLINE. ADDITIONALLY, ADVERSE REACTIONS WERE NOT

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127828 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT 15 MINUTES INTO A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) ON A SPECTRA OPTIA DEVICE, THE OPERATOR FAILED TO MAKE A COMPLETE SEAL IN THE SAMPLE POUCH BY THE INLET SITE. PER THE CUSTOMER, THE OPERATOR OBSERVED AIR GOING INTO THE INLET LINE (LUER CONNECTOR) AND CENTRIFUGE, AND THE OPERATOR BELIEVED AIR WAS GOING DIRECTLY INTO THE RETURN LINE. IT WAS REPORTED THAT THERE WERE NO ALARMS REGARDING THE RETURN LINE. THE PATIENT QUICKLY COMPLAINED OF SHORTNESS OF BREATH AND DIZZINESS. THE PATIENT WAS PUT ON OXYGEN (O2), POSITIONED ON THEIR LEFT SIDE, AND THE NURSE PRACTITIONER (NP) ORDERED A TRANSFER TO THE EMERGENCY ROOM (ER). ALL LEUR CONNECTIONS WERE TIGHT AND THERE WAS NO CLOTTING IN THE CHANNEL OR IN THE RETURN RESERVOIR. STOPCOCK WITH CALCIUM GLUCONATE IV LINE WAS CONNECTED TO THE RETURN LINE AT THE TIME OF THE EVENT. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 20101122 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE ""AUTOLOGOUS STEM CELL TRANSPLANT IN ADULT MULTIPLE SCLEROSIS PATIENTS: A STUDY FROM NORTH INDIA"" BY ANIRUDDHA DAYAMA, RAHUL BHARGAVA, SANTOSH R KURMI, SACHIN JAIN, VIKAS DUA ABSTRACT: INTRODUCTION: AUTOLOGOUS STEM CELL TRANSPLANT (ASCT) PROVIDES LONG PERIODS OF PROGRESSION-FREE-SURVIVAL IN MULTIPLE SCLEROSIS (MS). THIS IS AN OBSERVATIONAL STUDY TO DEMONSTRATE THE SAFETY OF ASCT IN MS PATIENTS AT A TRANSPLANT CENTER IN NORTH INDIA USING A LYMPHOABLATIVE REGIMEN. MATERIALS AND METHODS: MS PATIENTS > 18 YEARS REFERRED BY A NEUROLOGIST OR WHO CAME OF THEIR OWN VOLITION WERE EVALUATED. KURTZKE EXPANDED DISABILITY STATUS SCALE (EDSS) SCORE WAS CALCULATED AND THOSE WITH A SCORE OF >7 WERE EXCLUDED. INFORMED WRITTEN CONSENT WAS TAKEN. MOBILIZATION WAS DONE WITH G-CSF WITH PREDNISOLONE TO PREVENT DISEASE FLARE-UP. A MINIMUM OF 2 × 106 CD34 CELLS/KG WAS COLLECTED. CONDITIONING REGIMEN CONSISTED OF RABBIT ATG AND CYCLOPHOSPHAMIDE. RITUXIMAB 375 MG/M2 WAS GIVEN TO PREVENT EBV REACTIVATION AND DISEASE RELAPSE. ANTIBIOTIC PROPHYLAXIS WAS GIVEN WITH LEVOFLOXACIN, FLUCONAZOLE, AND VALACYCLOVIR. ANY PERSISTENT CHANGE IN EDSS SCORES =0.5 WAS CONSIDERED SIGNIFICANT. RESULTS: TWE

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

  MAUDE report 19920718 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE ""AUTOLOGOUS STEM CELL TRANSPLANT IN ADULT MULTIPLE SCLEROSIS PATIENTS: A STUDY FROM NORTH INDIA"" BY ANIRUDDHA DAYAMA, RAHUL BHARGAVA, SANTOSH R KURMI, SACHIN JAIN, VIKAS DUA ABSTRACT: INTRODUCTION: AUTOLOGOUS STEM CELL TRANSPLANT (ASCT) PROVIDES LONG PERIODS OF PROGRESSION FREE SURVIVAL IN MULTIPLE SCLEROSIS (MS). THIS IS AN OBSERVATIONAL STUDY TO DEMONSTRATE THE SAFETY OF ASCT IN MS PATIENTS AT A TRANSPLANT CENTER IN NORTH INDIA USING A LYMPHOABLATIVE REGIMEN. MATERIALS AND METHODS: MS PATIENTS 18 YEARS REFERRED BY A NEUROLOGIST OR WHO CAME OF THEIR OWN VOLITION WERE EVALUATED. KURTZKE EXPANDED DISABILITY STATUS SCALE (EDSS) SCORE WAS CALCULATED AND THOSE WITH A SCORE OF 7 WERE EXCLUDED. INFORMED WRITTEN CONSENT WAS TAKEN. MOBILIZATION WAS DONE WITH GCSF WITH PREDNISOLONE TO PREVENT DISEASE FLARE UP. A MINIMUM OF 2 106 CD34 CELLS/KG WAS COLLECTED. CONDITIONING REGIMEN CONSISTED OF RABBIT ATG AND CYCLOPHOSPHAMIDE. RITUXIMAB 375 MG/M2 WAS GIVEN TO PREVENT EBV REACTIVATION AND DISEASE RELAPSE. ANTIBIOTIC PROPHYLAXIS WAS GIVEN WITH LEVOFLOXACIN, FLUCONAZOLE, AND VALACYCLOVIR. ANY PERSISTENT CHANGE IN EDSS SCORES 0.5 WAS CONSIDERED SIGNIFICANT. RESULTS: TWENTY PAT

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

  MAUDE report 19920460 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "AUTOLOGOUS STEM CELL TRANSPLANT IN ADULT MULTIPLE SCLEROSIS PATIENTS: A STUDY FROM NORTH INDIA" BY ANIRUDDHA DAYAMA, RAHUL BHARGAVA, SANTOSH R KURMI, SACHIN JAIN, VIKAS DUA ABSTRACT: INTRODUCTION: AUTOLOGOUS STEM CELL TRANSPLANT (ASCT) PROVIDES LONG PERIODS OF PROGRESSION¿¿¿FREE¿¿¿SURVIVAL IN MULTIPLE SCLEROSIS (MS). THIS IS AN OBSERVATIONAL STUDY TO DEMONSTRATE THE SAFETY OF ASCT IN MS PATIENTS AT A TRANSPLANT CENTER IN NORTH INDIA USING A LYMPHOABLATIVE REGIMEN. MATERIALS AND METHODS: MS PATIENTS ¿¿¿ 18 YEARS REFERRED BY A NEUROLOGIST OR WHO CAME OF THEIR OWN VOLITION WERE EVALUATED. KURTZKE EXPANDED DISABILITY STATUS SCALE (EDSS) SCORE WAS CALCULATED AND THOSE WITH A SCORE OF ¿¿¿7 WERE EXCLUDED. INFORMED WRITTEN CONSENT WAS TAKEN. MOBILIZATION WAS DONE WITH G¿¿¿CSF WITH PREDNISOLONE TO PREVENT DISEASE FLARE¿¿¿UP. A MINIMUM OF 2 ¿¿ 106 CD34 CELLS/KG WAS COLLECTED. CONDITIONING REGIMEN CONSISTED OF RABBIT ATG AND CYCLOPHOSPHAMIDE. RITUXIMAB 375 MG/M2 WAS GIVEN TO PREVENT EBV REACTIVATION AND DISEASE RELAPSE. ANTIBIOTIC PROPHYLAXIS WAS GIVEN WITH LEVOFLOXACIN, FLUCONAZOLE, AND VALACYCLOVIR. ANY PERSISTENT CHANGE IN EDSS SCORES ¿¿¿0.5 WAS CONSIDERED SIGNIFICANT.

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

  MAUDE report 19920391 ↗
• MalfunctionJul 16, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE BLOOD WARMER DURING A PROCEDURE ON A SPECTRA OPTIA DEVICE. THE OPERATOR REMOVED THE AIR BUBBLES FROM THE BLOOD WARMER LINE AND CONTINUED THE PROCEDURE. PER THE CUSTOMER, THE OPERATOR DID NOT HAVE INTERFACE OR CELLS GOING THROUGH THE COLLECT PORT HOWEVER, THE DEVICE MESSAGE STATED, "COLLECTING CELLS". THE CUSTOMER DECLINED TO RESPOND TO MULTIPLE ATTEMPTS FOR FURTHER INFORMATION, THEREFORE, DONOR INFORMATION IS NOT AVAILABLE. NO MEDICAL INTERVENTION WAS REQUIRED. DONOR GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF). THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751611 ↗