Spectra Optia® 10120Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05020583101203), received between Nov 9, 2018 and Oct 23, 2025 — classified as 1 death, 15 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 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 DURING A MONONUCLEAR CELL (MNC) PROCEDURE A "LOW-LEVEL RESERVOIR SENSOR DETECTED AIR¿ ALARM OCCURRED AND FOAM WAS VISUALLY DETECTED IN THE RETURN LINE. THE OPERATOR DECIDED TO DISCONTINUE THE PROCEDURE. THE CD34 COLLECTION GOALS WERE ATTAINED. PATIENT INFORMATION IS UNKNOWN AT THIS TIME, GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF). PER CUSTOMER "PATIENT WAS CLINICALLY STABLE" AND NO MEDICAL INTERVENTION WAS 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 23367846 ↗
• InjuryNov 19, 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 ON THE SECOND DAY OF AUTOLOGOUS MONONUCLEAR CELL COLLECTION (MNC) PROCEDURES, THE PATIENT DEVELOPED A HIGH-GRADE FEVER IMMEDIATELY FOLLOWING THE PROCEDURE. PER CUSTOMER THE PATIENT WAS GIVEN PARACETAMOL AND IV TAZOCIN. BLOOD CULTURES FOR THESE PATIENTS HAVE RETURNED NEGATIVE. THE PATIENT IS IN STABLE CONDITION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Fever

  MAUDE report 20727408 ↗
• InjuryNov 19, 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 AFTER AN AUTOLOGOUS MONONUCLEAR CELL COLLECTION (MNC) PROCEDURE THE PATIENT DEVELOPED A HIGH-GRADE FEVER IMMEDIATELY FOLLOWING THE PROCEDURE. PER CUSTOMER THE PATIENT WAS GIVEN PARACETAMOL AND IV TAZOCIN. BLOOD CULTURES FOR THESE PATIENTS HAVE RETURNED NEGATIVE. THE PATIENT IS IN STABLE CONDITION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Fever

  MAUDE report 20726142 ↗
• InjuryNov 19, 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 ON THE 3RD DAY OF PROCEDURES, AFTER AN AUTOLOGOUS MONONUCLEAR CELL COLLECTION PROCEDURE THE PATIENT DEVELOPED A HIGH-GRADE FEVER IMMEDIATELY FOLLOWING THE PROCEDURE. PER CUSTOMER THE PATIENT WAS GIVEN PARACETAMOL. PATIENT BLOOD TEST CLOSTRIDIUM DIFFICILE +VE ((B)(6) 2024). THE PATIENT IS IN STABLE CONDITION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Fever

  MAUDE report 20725487 ↗
• MalfunctionApr 8, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING MACHINE PRIMING ON A SPECTRA OPTIA DEVICE, THE MACHINE DISPLAYED THE ERROR MESSAGE "RETURN AIR DETECTOR, TEST TO VERIFY LIQUID PRESENT IN THE RETURN LINE FAILED". THEY WERE ABLE TO RELOAD A NEW DISPOSABLE SET AND CONTINUE THE PROCEDURE. UPON REVIEW OF THE INFORMATION BY TERUMO BCT IT WAS NOTED THAT THE INCIDENT DATE OF THE EVENT WAS REPORTED AS 03/01/2024 AND THE SET EXPIRED 08/01/2023. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE EVENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061945 ↗
• MalfunctionDec 7, 2023Device Misassembled During Manufacturing /Shipping; Insufficient Device Problem Information; Device Misassembled During Manufacturing /Shipping; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE CLAMP'S POSITION WAS INCORRECT. THE ISSUE WAS NOTED WHEN CONNECTING THE PATIENT AND THE PROCEDURE WAS COMPLETED USING HEMOSTATS. PER THE CUSTOMER, THE FINAL FLUID BALANCE WAS 123%. FULL PATIENT ID (B)(6). THERE WAS NO MEDICAL INTERVENTION AND THE PATIENT IS IN STABLE CONDITION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hypervolemia

  MAUDE report 18283579 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER THE JOURNAL ARTICLE, "SUCCESSFUL AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTS USING SALMONELLA POSITIVE PRODUCTS COLLECTED FROM ASYMPTOMATIC DONORS." BY PHOU, S.,PEREZ-ALVAREZ, ET. AL. "THE PATIENT TOLERATED THE INFUSION WELL. ON DAY 4 POST-HSC INFUSION, SHE WAS STARTED ON LEVOFLOXACIN AS PART OF STANDARD INFECTIOUS DISEASE PROPHYLAXIS WHICH WAS SWITCHED TO CEFEPIME ON DAY 6 GIVEN TACHYCARDIA TO 110 BPM. ON DAY 8, SHE BEGAN HAVING ONGOING FEVERS (PEAKAT104¿¿F)AND CEFEPIME WAS SWITCHED TO MEROPENEM. ON DAY 10, SHE EXPERIENCED DIARRHEA. ON DAYS 11, 12, SHE DEVELOPED FACIAL ERYTHEMA, LEG SWELLING, APETECHIAL RASH ON THE UPPER EXTREMITIES, AND A TACHYCARDIC EPISODE TO 170 BPM. BLOOD CULTURES COLLECTED ON DAYS 6, 8, AND 12 WERE ALL NEGATIVE. GIVEN CONCERN FOR ENGRAFTMENT SYNDROME, SHE WAS GIVEN SOLUMEDROL ON DAYS 12,14 WITH TRANSITION TO APREDNISONE TAPER. SHE IMPROVED CLINICALLY AND WAS DISCHARGED ON DAY 15. NEUTROPHIL ENGRAFTMENT OCCURRED ON DAY 12 AND PLATELET ENGRAFTMENT BY DAY 25. ON FOLLOW UP DAY 85, SHE WAS DOING WELL CLINICALLY." THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. SPECIFIC DETAILS WERE NOT INCLUDED IN THE ARTICLE FOR TH

  Patient problems: Diarrhea; Erythema; Fever; Rash; Tachycardia

  MAUDE report 16935966 ↗
• 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 ALLO-WITH CLUMPING-TINGLING AND NUMBNESS BOTH ARMS, HYPOCALCAEMIA, MODERATE LEG PAIN, AC RATIO DECREASE FROM 12.0 TO 11.0 PATIENT OUTCOME IS 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 16881004 ↗
• 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 DLI-CAR-T-CELL-KITE-CARPO PEDAL SPASMS WITH CLUMPING AND TINGLING ON THE FACE, AC RATIO DECREASE FROM 12.0 TO 8.0 AND AC RATE INCREASE TO 1.5 PATIENT IDENTIFIER 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 16880852 ↗
• 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-ALLO- WITH CLUMPING, TINGLING(FINGERS AND LEGS), AC RATIO FROM 12.0 TO 10.0, RATE 1.2" THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER. PATIENT OUTCOME IS UNKNOWN. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Local Reaction

  MAUDE report 16878827 ↗
• 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 ALLO-WITH CLUMPING-SUDDEN CRAMPS, (BOTH LEGS AND ARMS, TETANY ( CARPOPEDAL SPASMS), TACHYCARDIA, HYPOTENSION, AND PANIC, AC RATIO FROM 12.0 TO 10.0, AC RATE 1.2 THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER. PATIENT OUTCOME IS UNKNOWN. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Local Reaction

  MAUDE report 16878824 ↗
• 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 ALLO-WITH CLUMPING-TINGLING AND LEFT SHOULDER PAIN UPPER AND LOWER EXTREMITIES, AC RATIO FROM 12.0 TO 10.0, AC RATE 1.5 PATIENT IDENTIFIER 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 16878823 ↗
• 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 DLI-ALLO- WITH CLUMPING, TINGLING(FINGERS AND ARMS), AC RATIO FROM 12.0 TO 8.0, RATE 1.2. PATIENT IDENTIFIER 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 16877329 ↗
• 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. AN ALLOGENIC PBSC COLLECTION FOR A HEALTHY FEMALE PATIENT THE TOTAL BLOOD VOLUME (TBV) PROCESSED WAS 4=12024ML. AFTER ABOUT ONE HOUR FROM THE START OF THE PROCEDURE A SIGNIFICANT CLUMPING NOTED ALONG THE PLASMA LINE THEREFORE, AC RATIO WAS REDUCED TO 10:1, BUT THE CLUMPING IS STILL THE SAME SO THE AC RATIO REDUCED AGAIN TO 8:1. AC INFUSION RATE INCREASED TO 1.4 AND THEN TO 1.5 TO MAINTAIN A SUFFICIENT INLET FLOW RATE. THE DONOR STARTED TO COMPLAIN OF MILD CITRATE REACTION AND THEN EXACERBATED TO MODERATE REACTION EVEN WITH BOLUS DOSES OF CALCIUM INFUSION. THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER. PATIENT OUTCOME IS UNKNOWN. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Local Reaction

  MAUDE report 16876935 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; No Apparent Adverse Event

  THE JOURNAL ARTICLE, 'THE DETERMINANTS OF DONOR SAFETY AND PRODUCT QUALITY IN OPTIMIZATION OF APHERESIS GRANULOCYTE HARVEST: AN EXPERIENCE FROM A TERTIARY CARE ONCOLOGY CENTRE IN INDIA' DESCRIBES A RETROSPECTIVE STUDY ON 131 HEALTHY ALLOGENEIC DONORS WHO UNDERWENT GRANULOCYTE HARVEST FROM MAY 2016 TO JULY 2020. DONORS WERE MOBILIZED FOR GRANULOCYTE HARVEST 10-12 HOURS BEFORE COLLECTION WITH 10 ¿G/KG SUBCUTANEOUS INJECTION OF G-CSF PLUS 8 MG ORAL DEXAMETHASONE TABLETS AND WERE SUBJECTED TO APHERESIS COLLECTION USING DIFFERENT CELL SEPARATORS LIKE COBE SPECTRA MNC SYSTEM (TERUMO BCT), FRESENIUS COM.TEC MNC SYSTEM (FRESENIUS KABI), AND SPECTRA OPTIA MNC SYSTEM (TERUMO BCT). DONOR'S AGES RANGED BETWEEN 20 TO 55 YEARS WITH A MEDIAN AGE OF 32 YEARS AND INCLUDED 129 MALES AND TWO FEMALE DONORS. ADVERSE EVENTS (AES) WERE OBSERVED IN OVERALL 29 PROCEDURES (22.13%), INCLUDING 14.50% CITRATE REACTIONS, 7.6% VENOUS ACCESS-RELATED REACTIONS, AND 1.52% VASOVAGAL REACTIONS. ALL THE AES WERE CLASSIFIED AS GRADE I AND GRADE II AS PER THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) GRADING VERSION 5.0, WHICH REQUIRED MINIMAL INTERVENTION. - IV CALCIUM FOR REACTION. THE ARTICLE DID NOT PRO

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15815756 ↗
• InjuryNov 14, 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 JOURNAL ARTICLE, PERIPHERAL BLOOD STEM CELLS COLLECTION BY APHERESIS IN VERY LOW-WEIGHT CHILDREN WITH MALIGNANT DISEASES-A SINGLE CENTER EXPERIENCE, DESCRIBES A RETROSPECTIVE STUDY ON PEDIATRIC PERIPHERAL BLOOD STEM CELL (PBSC) COLLECTION IN PATIENTS WEIGHING UNDER 10KG, BETWEEN 2006-2021. UNTIL 2012, COBE SPECTRA APHERESIS SYSTEM (VERSION 6.1, TERUMOBCT, LAKEWOOD, COLORADO) WAS USED. SINCE THEN, SPECTRA OPTIA (VERSION 11.3, TERUMOBCT) WAS USED. SIXTEEN APHERESIS PROCEDURES, PERFORMED IN 13 PATIENTS WITH UP TO 10 KG OF BODY WEIGHT, WERE ANALYZED. THE STUDY DESCRIBED THE FOLLOWING ADVERSE EVENTS (AES) - PRE-APHERESIS ANEMIA WAS PRESENT IN ALL PROCEDURES AND WORSENED IN SEVEN OF THEM (IT PROGRESSED FROM GRADES 1 TO 2 IN FIVE OF THE SESSIONS AND FROM GRADES 2 TO 3 IN TWO OTHERS). PRE-PROCEDURE GRADE 1 THROMBOCYTOPENIA WAS PRESENT IN ONE CASE, AND PROGRESSED TO GRADE 2 AFTER THE COLLECTION. OF THE REMAINDER, ALL WITH BASELINE NORMAL PLATELET COUNTS, EIGHT PROGRESSED TO GRADE 1 THROMBOCYTOPENIA. APHERESIS-RELATED HYPOKALEMIA OCCURRED IN ONE CASE. SUPPLEMENTATION WITH INTRAVENOUS MAGNESIUM SULFATE WAS REQUIRED IN ONE PATIENT WITH HYPOMAGNESEMIA AND UNSPECIFIED IRRITABILITY; PARACETAM

  Patient problems: Electrolyte Imbalance; Hypersensitivity/Allergic reaction

  MAUDE report 15788203 ↗
• InjurySep 15, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER THE ARTICLE, 'DEXMEDETOMIDINE FOR SEDATION DURING HEMATOPOIETIC STEM CELL HARVEST APHERESIS AND LEUKAPHERESIS IN THE PICU: GUIDELINE DEVELOPMENT', CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION PROTOCOLS WERE USED ON HIGH-RISK PEDIATRIC PATIENTS WHO REQUIRED SEDATION FOR HEMATOPOIETIC STEM CELL (HSC) HARVEST APHERESIS PROCEDURES. A GUIDELINE WAS DEVELOPED TO PROVIDE A STANDARDIZED SEDATION PLAN FOR THE HIGH-RISK PATIENTS REQUIRING HSC OR LYMPHOCYTE APHERESIS IN THE PICU WITH THE USE OF DEXMEDETOMIDINE. PRIOR TO APHERESIS, THESE PATIENTS ALL HAVE CENTRAL VENOUS ACCESS EITHER WITH THEIR EXISTING CENTRAL VENOUS CATHETERS, PORTS, OR REQUIRE PLACEMENT OF AN APHERESIS CATHETER (CVL), IN INTERVENTIONAL RADIOLOGY (IR). ONE PATIENT HAD TO EXTEND THE COLLECTION SLIGHTLY DUE TO DISRUPTION FROM PLATELET CLUMPING TO ENSURE QUALITY OF PRODUCT COLLECTION, ANOTHER PATIENT REQUIRED 0.5L SUPPLEMENTAL OXYGEN VIA SIMPLE NASAL CANNULA FOR DESATURATION TO THE 80S. PRE-GUIDELINE, ONE PATIENT EXPERIENCED HYPOTENSION AND REQUIRED EPINEPHRINE, IV FLUID BOLUS, ELECTROLYTE REPLACEMENTS AND HALTING OF THE APHERESIS PROCEDURE UNTIL THE FOLLOWING DAY. THREE PATIENTS REQUIRED SECOND OR THIRD DAYS IN THE PICU F

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 15428829 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem

  THIS IS A RETROSPECTIVE DATA ANALYSIS OF 150 PATIENTS WHO HAD UNDERGONE PERIPHERAL BLOOD STEM CELL COLLECTION AT A SINGLE INSTITUTION BETWEEN MARCH OF 2014 AND MAY OF 2015. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE. COLLECTION REGIMEN TWO STEP CONTINUOUS PATIENT NUMBER N=47 N=41 AGE (YEARS) 62 (44¿79) 55 (40¿70) MALE N=26 N=23 FEMALE N=21 N=18 BODY WEIGHT (KG) 79 (54¿108) 80 (54¿118). FROM MARCH TO NOVEMBER OF 2014, PBSC COLLECTION WAS CARRIED OUT AS A TWO-STEP SEPARATION PROCEDURE (MNC SOFTWARE VERSION 7.2). FROM NOVEMBER OF 2014, A CONTINUOUS PBSC COLLECTION METHOD (MNC SOFTWARE VERSION 11.2) WAS USED. TO ACHIEVE HOMOGENIZATION, THE PATIENTS WERE SUBDIVIDED INTO TWO GROUPS BY DIAGNOSIS AND PREVIOUS FORMS OF THERAPY RECEIVED: A HOMOGENEOUS SUBGROUP OF MM PATIENTS (N=88) UNDERGOING FIRST LINE THERAPY AND A HETEROGENEOUS GROUP COMPOSED OF THE REST OF THE PATIENTS (N=62). OVERALL, 116 (61 TWO-STEP, 55 CONTINUOUS) LEUKAPHRESIS (LP) PROCEDURES FOR MM PATIENTS AND 76 (37 TWO-STEP, 39 CONTINUOUS) LP SESSIONS FOR PATIENTS WITH OTHER ENTITIES WERE EVALUATED (TABLE II). THE MM AND NON-MM PATIENTS DID NOT SHOW ANY SIGNIFICANT DIFFERENCES IN TERMS OF CD341 COLLECTION YIELDS F

  Patient problems: Blood Loss

  MAUDE report 10421442 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem

  THIS IS A RETROSPECTIVE DATA ANALYSIS OF 19 CHILDREN UNDERWENT HPC COLLECTION BETWEEN 2003 AND 2014, 12 BOYS AND 7 GIRLS. THE MEDIAN AGE AT THE LEUKAPHERESIS WAS 5 YEARS OLD (RANGE, <1¿15 YEARS OLD) AND MEDIAN WEIGHT OF 16.8 KG (RANGE, 6.7-42 KG); 17 PATIENTS HAD LESS THAN OR EQUAL TO 30 KG AND THREE OF THEM LESS THAN OR EQUAL TO 10 KG. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Reaction

  MAUDE report 10420515 ↗
• DeathAug 18, 2020Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem; Self-Activation or Keying

  THIS IS A RETROSPECTIVE DATA ANALYSIS OF 19 CHILDREN UNDERWENT HPC COLLECTION BETWEEN 2003 AND 2014, 12 BOYS AND 7 GIRLS. THE MEDIAN AGE AT THE LEUKAPHERESIS WAS 5 YEARS OLD (RANGE, <1¿15 YEARS OLD) AND MEDIAN WEIGHT OF 16.8 KG (RANGE, 6.7-42 KG); 17 PATIENTS HAD LESS THAN OR EQUAL TO 30 KG AND THREE OF THEM LESS THAN OR EQUAL TO 10 KG. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Death

  MAUDE report 10420502 ↗
• InjuryAug 17, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE ARTICLE, 'IMPROVED PLANNING OF LEUKAPHERESIS ENDPOINT WITH CUSTOMIZED PREDICTION ALGORITHM: MINIMIZING COLLECTION DAYS, VOLUME OF BLOOD PROCESSED, PROCEDURE TIME, AND CITRATE TOXICITY' (LEBERFINGER 2017), A RETROSPECTIVE ANALYSIS WAS PERFORMED ON 107 HPC COLLECTIONS COMPLETED ON THE SPECTRA OPTIA MNC FROM JANUARY 2013 TO JUNE 2014 IN 51 PATIENTS AND 12 DONORS. IN DECEMBER 2014, A PREDICTION ALGORITHM WAS IMPLEMENTED, DESIGNED FROM DATA ACQUIRED SINCE JANUARY 2013, BY LINEAR REGRESSION OF PREAPHERESIS CD34 CELL COUNTS (PRE-CD34) VERSUS COLLECTED CD34 CELL DOSE PER VOLUME BLOOD PROCESSED. ALL APHERESIS COLLECTIONS WERE PERFORMED ON THE SPECTRA OPTIA (TERUMO BCT) USING THE MNC PROTOCOL (SOFTWARE VERSIONS 6, 9, AND 11). A 12:1 INLET:ANTICOAGULANT (AC) RATIO WAS USED FOR BOTH ALLOGENEIC AND AUTOLOGOUS PROCEDURES, WITH A MEAN INFUSION RATE OF 0.9 ML/MIN/TBV (RANGE, 0.7-1.2 ML/MIN). CALCIUM WAS ADMINISTERED SYMPTOMATICALLY: ORAL CALCIUM CARBONATE SUPPLEMENTATION (2 3 750 MG) OR INTRAVENOUS (IV) CALCIUM GLUCONATE (2 G IN 50-500 ML NORMAL SALINE SOLUTION). FROM THE 94 AUTOLOGOUS PROCEDURES, FIVE PROCEDURES REQUIRED IV ADMINISTRATION OF CALCIUM GLUCONATE, AND IN SIX PROCEDURES BOTH I

  Patient problems: Reaction

  MAUDE report 10413930 ↗
• MalfunctionJul 8, 2020Backflow; Use of Device Problem; Device Displays Incorrect Message; Use of Device Problem

  THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER DUE TO EU DATA PROTECTION LAWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10247711 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN AUTOLOGOUS PATIENT WITH NON-HODGKIN'S LYMPHOMA EXPERIENCED A REACTION DURING A COLLECTION PROCEDURE. THE PATIENT PRESENTED CHILLS, NAUSEA, RESTLESSNESS, HEADACHE, BILIARY VOMIT, HYPERTHERMIA (TEMPERATURE INCREASE FROM 37 TO 40 DEGREES CELSIUS IN <10 MINUTES), AND TACHYCARDIA OF 131 BEATS PER MINUTE (STARTING PULSE RATE WAS 90BPM). THERE WERE NO SIGNS OF MUSCLE SPASMS, CHEVOSTEK SIGNS, SIGNS OF TROUSSEAU, TETANY, ARRHYTHMIA, SEIZURE, TINGLING SENSATION, OR PARESTHESIAS. TWO AMPULES WITH 1 GRAM EACH OF CALCIUM GLUCONATE WERE ADMINISTERED. HYDROCORTISONE WAS ALSO ADMINISTERED. PATIENT IDENTIFIER, AGE AND OUTCOME ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Chills; Reaction; Tachycardia

  MAUDE report 9739551 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem

  PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE FROM THE CUSTOMER.

  Patient problems: Chills; Reaction; Tachycardia

  MAUDE report 9739367 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN AUTOLOGOUS PATIENT WITH NON-HODGKIN¿S LYMPHOMA EXPERIENCED A REACTION DURING A COLLECTION PROCEDURE. THE PATIENT PRESENTED CHILLS, NAUSEA, RESTLESSNESS, HEADACHE, BILIARY VOMIT, HYPERTHERMIA (TEMPERATURE INCREASE FROM 37 TO 39 DEGREES CELSIUS), AND TACHYCARDIA OF 131 BEATS PER MINUTE. THERE WERE NO SIGNS OF MUSCLE SPASMS, CHVOSTEK SIGNS, SIGNS OF TROUSSEAU, TETANY, ARRHYTHMIA, OR SEIZURE. TWO AMPULES WITH 1 GRAM EACH OF CALCIUM GLUCONATE WERE ADMINISTERED. HYDROCORTISONE WAS ALSO ADMINISTERED. THE PATIENT'S SYMPTOMS REVERSED AFTER THREE HOURS. PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Chills; Reaction; Tachycardia

  MAUDE report 9739265 ↗