Spectra Optia® 10110Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05020583101104), received between Sep 17, 2018 and Aug 23, 2024 — classified as 2 deaths, 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 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 "PERSONALIZED AUTOLOGOUS STEM CELL HARVESTING IMPROVES PATIENT COLLECTION OUTCOMES". BY DUARTE, G.D.C., WEI, W POTENTIAL ADVERSE EVENT : THERE WERE 52 (51 MILD, 1 MODERATE) AND 50 (49 MILD, 1 MODERATE) ADVERSE EVENTS REPORTED FROM THE OSFA AND CT STRATEGY RESPECTIVELY, COUNTING FOR 45.5% AND 35% OF THE HARVESTING PROCEDURES FOR EACH GROUP. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS 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

  MAUDE report 20054592 ↗
• InjuryAug 23, 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, "OPTIMIZED PERIPHERAL BLOOD PROGENITOR CELL MOBILIZATION FOR AUTOLOGOUS HEMATOPOIETIC CELL TRANSPLANTATION IN CHILDREN WITH HIGH-RISK AND REFRACTORY MALIGNANCIES", BY FURLONG, E., JENSEN, J., WOODARD, M., GRIFFITHS, K., KNIGHT, G., STURM, M., KERR, F., GOUGH, H., BEAR, N., CARTER, T. L., COLE, C. H., KOTECHA, R. S., & RAMACHANDRAN, S., A RETROSPECTIVE STUDY OF 125 PEDIATRIC PATIENTS WITH HIGH-RISK MALIGNANCIES UNDERGOING AHSCT IN WESTERN AUSTRALIA BETWEEN 1997 AND 2016 WAS CONDUCTED. MOBILIZATION WAS ACHIEVED BY MEANS OF CHEMOTHERAPY AND GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF). PATIENTS UNDERWENT APHERESIS THE DAY AFTER CD34+ COUNTS REACHED =20/L AND AN ADDITIONAL DOSE OF G-CSF. PERIPHERAL ARTERIAL AND INTRAVENOUS LINES WERE INSERTED IN PEDIATRIC INTENSIVE CARE UNIT UNDER LOCAL ANESTHETIC AND/OR SEDATION, OMITTING THE NEED FOR GENERAL ANESTHESIA AS WELL AS FACILITATING AN UNINTERRUPTED APHERESIS FLOW. LARGER APHERESIS TOTAL BLOOD VOLUMES WERE PROCESSED IN PATIENTS WEIGHING =20 KG. THE MINIMAL DOSE OF =2 × 106 CD34+ CELLS/KG WAS SUCCESSFULLY COLLECTED IN 98.4% OF ALL PATIENTS. THE OPTIMAL DOSE OF 3-5 × 106 CD34+ CELLS/KG WAS COLLECTED IN 96% OF PATIENTS SC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension

  MAUDE report 20054354 ↗
• MalfunctionMay 5, 2023Adverse 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 ADVERSE REACTION (CITRATE) FOR CELLULAR COLLECTION DATA DURING DONATIONS ON AN OPTIA DEVICE. THE PATIENT REPORTED HPCA AUTO-WITH CLUMPING-STIFFNESS OF FINGER TIPS. 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: Local Reaction

  MAUDE report 16876291 ↗
• MalfunctionOct 4, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING FOUR MONONUCLEAR CELL COLLECTION PROCEDURES ON FOUR DIFFERENT DEVICES, THE DEVICE COULDN¿T ESTABLISH INTERFACE FOR A LONG TIME AND KEPT ALARMING FOR THE SAME REASON. PER THE CUSTOMER, THEY KEPT LOWERING THE HEMATOCRIT BY 3% UNTIL REACHING 21% TO BE ABLE TO START COLLECTION. THE PATIENT'S CBC ON THE 3RD DAY RESULTS WERE HEMATOCRIT:34.1, HEMOGLOBIN: 10.7, WBC 55.410^6 & PLATELET: 12310^3. PER THE CUSTOMER, THE PATIENT DID NOT HAVE HYPERVISCOUS BLOOD, BUT DOES HAVE ELEVATED IMMUNOGLOBULIN. PER THE CUSTOMER, FOR TWO CONSECUTIVE DAYS A LOT OF AIR WAS FOUND IN THE LINE AND THE OPERATOR MADE SURE THAT THE LINE WERE SECURED AND TIGHT AND THERE WERE NO LOADING ISSUES. PER THE CUSTOMER, MEDICAL INTERVENTION WAS NECESSARY, HOWEVER DETAILS OF THE MEDICAL INTERVENTION ARE NOT AVAILABLE AT THIS TIME. PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THE SET IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 15537444 ↗
• MalfunctionOct 4, 2022Adverse 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 FOUR MONONUCLEAR CELL COLLECTION PROCEDURES ON FOUR DIFFERENT DEVICES, THE DEVICE COULDN¿T ESTABLISH INTERFACE FOR A LONG TIME AND KEPT ALARMING FOR THE SAME REASON. PER THE CUSTOMER, THEY KEPT LOWERING THE HEMATOCRIT BY 3% UNTIL REACHING 21% TO BE ABLE TO START COLLECTION. THE PATIENT'S CBC ON THE 3RD DAY RESULTS WERE HEMATOCRIT:34.1, HEMOGLOBIN: 10.7, WBC 55.410^6 & PLATELET: 12310^3. PER THE CUSTOMER, THE PATIENT DID NOT HAVE HYPERVISCOUS BLOOD, BUT DOES HAVE ELEVATED IMMUNOGLOBULIN. PER THE CUSTOMER, FOR TWO CONSECUTIVE DAYS A LOT OF AIR WAS FOUND IN THE LINE AND THE OPERATOR MADE SURE THAT THE LINE WERE SECURED AND TIGHT AND THERE WERE NO LOADING ISSUES. PER THE CUSTOMER, MEDICAL INTERVENTION WAS NECESSARY, HOWEVER DETAILS OF THE MEDICAL INTERVENTION ARE NOT AVAILABLE AT THIS TIME. PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THE SET IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537335 ↗
• MalfunctionOct 4, 2022Adverse 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 FOUR MONONUCLEAR CELL COLLECTION PROCEDURES ON FOUR DIFFERENT DEVICES, THE DEVICE COULDN¿T ESTABLISH INTERFACE FOR A LONG TIME AND KEPT ALARMING FOR THE SAME REASON. PER THE CUSTOMER, THEY KEPT LOWERING THE HEMATOCRIT BY 3% UNTIL REACHING 21% TO BE ABLE TO START COLLECTION. THE PATIENT'S CBC ON THE 3RD DAY RESULTS WERE HEMATOCRIT:34.1, HEMOGLOBIN: 10.7, WBC 55.410^6 & PLATELET: 12310^3. PER THE CUSTOMER, THE PATIENT DID NOT HAVE HYPERVISCOUS BLOOD, BUT DOES HAVE ELEVATED IMMUNOGLOBULIN. PER THE CUSTOMER, FOR TWO CONSECUTIVE DAYS A LOT OF AIR WAS FOUND IN THE LINE AND THE OPERATOR MADE SURE THAT THE LINE WERE SECURED AND TIGHT AND THERE WERE NO LOADING ISSUES. PER THE CUSTOMER, MEDICAL INTERVENTION WAS NECESSARY, HOWEVER DETAILS OF THE MEDICAL INTERVENTION ARE NOT AVAILABLE AT THIS TIME. PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THE SET IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537268 ↗
• MalfunctionOct 4, 2022Adverse 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 FOUR MONONUCLEAR CELL COLLECTION PROCEDURES ON FOUR DIFFERENT DEVICES, THE DEVICE COULDN¿T ESTABLISH INTERFACE FOR A LONG TIME AND KEPT ALARMING FOR THE SAME REASON. PER THE CUSTOMER, THEY KEPT LOWERING THE HEMATOCRIT BY 3% UNTIL REACHING 21% TO BE ABLE TO START COLLECTION. THE PATIENT'S CBC ON THE 3RD DAY RESULTS WERE HEMATOCRIT:34.1, HEMOGLOBIN: 10.7, WBC 55.410^6 & PLATELET: 12310^3. PER THE CUSTOMER, THE PATIENT DID NOT HAVE HYPERVISCOUS BLOOD, BUT DOES HAVE ELEVATED IMMUNOGLOBULIN. PER THE CUSTOMER, FOR TWO CONSECUTIVE DAYS A LOT OF AIR WAS FOUND IN THE LINE AND THE OPERATOR MADE SURE THAT THE LINE WERE SECURED AND TIGHT AND THERE WERE NO LOADING ISSUES. PER THE CUSTOMER, MEDICAL INTERVENTION WAS NECESSARY, HOWEVER DETAILS OF THE MEDICAL INTERVENTION ARE NOT AVAILABLE AT THIS TIME. PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THE SET IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537178 ↗
• DeathDec 27, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WHILE UNDERGOING AN EMERGENCY WHITE BLOOD CELL DEPLETION (WBCD) PROCEDURE,THE PATIENT EXPIRED DUE TO A HEART ATTACK. THE CUSTOMER IS NOT ALLEGING ANY PROBLEM WITH THE MACHINE OR THE WBCD SET AND IS "CONSIDERING TO" BE DUE TO THE PATIENT¿S MEDICAL CONDITION AT THE TIME. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, ALTHOUGH PER CURRENT INFORMATION THERE IS NO SUSPECTED MALFUNCTION WITH THE TERUMO BCT DEVICE OR ALLEGATION OF A MALFUNCTION. THE CUSTOMER DECLINED TO PROVIDE ANY INFORMATION FOR THE INVESTIGATION SUCH AS PROCEDURAL DETAILS, SET INFORMATION AND LOT INFORMATION.

  Patient problems: Death

  MAUDE report 8199598 ↗
• DeathOct 9, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT POST A MONO NUCLEAR CELL (MNC) COLLECTION ON THE SPECTRA OPTIA, THE PATIENT EXPIRED. PER THE CUSTOMER, THEY ARE UNSURE IF THE DEATH WAS RELATED TO THE PROCEDURE. THE PATIENT'S VASCULAR ACCESS WAS A CENTRAL LINE. PATIENT AGE IS NOT AVAILABLE AT THIS TIME. THE PATIENT'S GENDER WAS OBTAINED FROM THE RUN DATA FILE (RDF). THE LOT NUMBER, MANUFACTURE DATE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, ALTHOUGH PER CURRENT INFORMATION THERE IS NO SUSPECTED MALFUNCTION WITH THE TERUMO BCT DEVICE OR ALLEGATION OF A MALFUNCTION.

  Patient problems: Death

  MAUDE report 7949911 ↗
• InjurySep 17, 2018Unstable; Use of Device Problem; Structural Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THEY HAD COLLECTION ISSUES DURING A SPECTRA OPTIA MONONUCLEAR CELL(MNC) COLLECTION. THEY TRIED TWO PROCEDURES ON TWO DIFFERENT MACHINES WITH THE SAME LOT NUMBER AND BOTH TIMES THEY DID NOT HAVE ANY RED BLOOD CELLS (RBCS) IN THE COLLECTION CHAMBER. THE CUSTOMER CLAIMED ON THE FIRST COLLECTION, THE INTERFACE WAS STABLE AND THE COLLECTION PREFERENCES WERE LOWERED. THEY DISCOVERED THE COLLAR WAS SECURE BUT THEN SPLIT AND BECAME UNSECURED. THE COLLECTION WAS DISCONTINUED. THEY LOADED ANOTHER MACHINE WITH THE SAME LOT NUMBER AND CLAIMED THE SAME THING OCCURRED AND NO CELLS WERE IN THE COLLECTION CHAMBER. PER THE CUSTOMER, DUE TO TWO UNSUCCESSFUL COLLECTIONS, THE PATIENT WAS GIVEN GCSF, AN UNPLANNED MEDICATION ON THAT DAY TO ENHANCE THE PATIENTS¿ CELLS TO TRY FOR ANOTHER COLLECTION THE FOLLOWING DAY. NO REPORT OF INJURY TO THE PATIENT. PER THE CUSTOMER, THE FOLLOWING DAY A HARVEST COLLECTION WAS PERFORMED SUCCESSFULLY WITH A DIFFERENT LOT NUMBER. PATIENT ID, DATE OF BIRTH, AND WEIGHT ARE NOT AVAILABLE AT THIS TIME. THE MNC SPECTRA OPTIA COLLECTION SET IS NOT AVAILABLE BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881163 ↗