Spectra Optia® 10310Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 05020583103108), received between Aug 30, 2018 and May 4, 2026 — classified as 6 deaths, 51 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (28 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Customer reported that during a Car-T apheresis procedure on an Optia device, air bubbles were detected in the chamber and the procedure stopped. The device provided a run ending alarm. The customer declined to provide patient information. Patient¿s gender and weight were obtained from the run data file (RDF). Per customer "Patient did not have any complication due to the procedure /event " 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 25069945 ↗
• MalfunctionApr 23, 2026Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem

  THE CUSTOMER REPORTED THAT THE AC SPIKE AND THE SALINE SPIKE WERE MISTAKENLY INTERCHANGED DURING A PROCEDURE ON SPECTRA OPTIA. THE ISSUE WAS NOTICED DURING THE PROCEDURE AND THE PROCESSING WAS TERMINATED. THE PATIENT EXPERIENCED NUMBNESS DUE TO HYPOCALCEMIA AT AN EARLY STAGE AFTER THE START OF COLLECTION. THE IONIZED CALCIUM LEVEL MEASURED AT THAT TIME WAS 1.2 MMOL. WHEN THE CUSTOMER CONTACT A TBCT REPRESENTATIVE, HE ADVISED THAT RINSEBACK SHOULD NOT BE PERFORMED; HOWEVER, BY THAT TIME, THE SALINE HAD ALREADY BEEN RECONNECTED TO THE INLET SIDE MANIFOLD AND RINSEBACK HAD BEEN PERFORMED. PER THE CUSTOMER, "THE SYMPTOMS SUBSEQUENTLY IMPROVED" PATIENT INFORMATION IS UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Numbness

  MAUDE report 24969220 ↗
• MalfunctionApr 2, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER STATED THAT DURING A COLLECTION, THE PATIENT DEVELOPED ITCHING APPROXIMATELY ONE HOUR AFTER THE START OF THE PROCEDURE, AND WHEALS APPEARED ABOUT TWO HOURS AFTER START. AS A RESULT, THE PROCEDURE WAS DISCONTINUED. FOLLOWING ADMINISTRATION OF SOLU-CORTEF AND POLARAMINE, THE SKIN RASH GRADUALLY IMPROVED. THEREAFTER, NO ADDITIONAL ANTI-ALLERGIC AGENTS WERE ADMINISTERED, AND NO RECURRENCE WAS OBSERVED. PATIENT ID IS NOT AVAILABLE AT THIS TIME. TERUMO BCT IS AWAITING RETURN OF THE COLLECTION SET FOR EVALUATION.

  Patient problems: Itching Sensation; Urticaria; Wheal(s)

  MAUDE report 24769233 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROCEDURE A HIGH-RISK NEUROBLASTOMA PATIENT EXPERIENCED CHILLS, TACHYCARDIA, AND FEVER. WHEN THE PATIENT STARTED SHIVERING, THEY WERE GIVEN AVIL AND THE PROCEDURE WAS STOPPED. MEDICAL INTERVENTION THAT WAS GIVEN WAS AVIL AND PARACETAMOL. FULL PATIENT IDENTIFIER - (B)(6) PER CUSTOMER PATIENT IS "ALIVE" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Chills; Fever; Tachycardia

  MAUDE report 24416353 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT A CONTINUOUS MULTINUCLEAR CELL COLLECTION (CMNC) PROCEDURE WITH ALBUMIN PRIMING. MID PROCEDURE, THE PATIENT HAD ONE FEVER SPIKE WITH CHILLS, ASSOCIATED WITH TACHYCARDIA AND HYPOTENSION. AN IVF NORMAL SALINE (NS) BOLUS AND IV CEFTRIAXONE WAS GIVEN. THE PATIENT DEVELOPED A HIGH-GRADE FEVER AND HAD MULTIPLE EPISODES OF VOMITING. TACHYCARDIA AND HYPOTENSION PERSISTED AND THE IVF BOLUS WAS REPEATED. BLOOD WORKUP INDICATED RISING PROCALCITONIN (>100), ANTIBIOTICS WERE UPGRADED TO IV MEROPENEM AND AMIKACIN. DUE TO A FLUID REFRACTORY SHOCK, THE PATIENT WAS STARTED ON INJ NOR-ADRENALINE INFUSION. REPEAT LABS SHOWED HB 7 AND PLATELET 35000, SO A PACKED RED BLOOD CELL (PRBC) TRANSFUSION WAS GIVEN. THE PROCEDURE WAS TERMINATED EARLY. ELECTROLYTE CORRECTION WAS GIVEN AS PER REPORTS. NOR-ADRENALINE INFUSION WAS GRADUALLY TAPERED AND STOPPED ON (B)(6) 2025. CURRENT PATIENT STATUS IS "ALIVE". FULL PATIENT ID: (B)(6) THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Chills; Fever; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 24326943 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A PATIENT THEN UNDERWENT A SECOND HARVEST PROCEDURE WITH PRBC PRIMING. DURING THE PROCEDURE, THE PATIENT DEVELOPED A HEADACHE, FEVER, CHILLS AND VOMITING. THE PROCEDURE WAS ABORTED, AS THE PATIENT HAD TACHYCARDIA WITH HYPOTENSION. IVF NS BOLUS GIVEN. STAT DOSE OF IV METHYL PREDNISOLONE AND ANTIHISTAMINES WAS GIVEN. IV STEROIDS REPEATED I/V/O HYPOTENSION. PATIENT REQUIRED NORADRENALINE INFUSION DUE TO PERSISTENT HYPOTENSION. NO REPEAT FEVER AND VOMITING. PROCAL HAD INCREASED TO 54 ON (B)(6) 2026. NORADRENALINE TAPERED AND STOPPED ON (B)(6) 2026. FULL PATIENT IDENTIFIER: (B)(6) THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Fever; Low Blood Pressure/ Hypotension; Tachycardia; Vomiting

  MAUDE report 24326701 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT HARVEST ON (B)(6) 2026, NO PRIMING REQUIRED. DURING THE PROCEDURE, THE PATIENT DEVELOPED CHILLS AND WAS GIVEN IV ANTIHISTAMINES AND METHYL PREDNISOLONE. PATIENT HAD TACHYCARDIA AND HYPOTENSION WITH COLD EXTREMITIES, IVF BOLUS WAS STARTED. PATIENT HAD HYPOTHERMIA. HYPOTENSION PERSISTED; IVF NS BOLUS WAS REPEATED. THE PATIENT DEVELOPED ONE FEVER SPIKE AND A WORKUP SHOWED RISING CRP; IV CEFTRIAXONE WAS GIVEN. IV MPS WAS REPEATED. PROCEDURE WAS TERMINATED EARLY. THE PATIENT WAS IN FLUID REFRACTORY SHOCK AND HAD A REPEATED FEVER SPIKE AND WAS STARTED ON IN NORADRENALINE INFUSION. CRP UPTRENDING OCCURRED WITH RAISED PROCALCITONIN. FEVER WORK-UP SENT AND A STERILE CULTURE WAS RECEIVED, HOWEVER, THE PATIENT CONTINUED ON ROUND THE CLOCK ANTIHISTAMINES. ANTIBIOTICS SHIFTED TO LEVOFLOXACIN. INJ NORADRENALINE TAPERED AND STOPPED ON (B)(6) 2026. PATIENT ID IS NOT AVAILABLE AT THIS TIME. PATIENT IS REPORTED AS "ALIVE" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: High Blood Pressure/ Hypertension; Hyperthermia; Insufficient Information; Tachycardia

  MAUDE report 24326578 ↗
• InjuryAug 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

  PER JOURNAL ARTICLE "VASCULAR ACCESS FOR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS COLLECTION BY LARGE VOLUME LEUKAPHERESIS: SINGLE CENTER EXPERIENCE" BY BOJANI, I., NOVOSEL, G., LUKA BARIEVI, M.,KRNJUG, P., HORVAT, E., MAZI, S., BATINI, J., KINDA, S.B., EPULI, B.G.. POTENTIAL ADVERSE EVENT : ADVERSE REACTIONS RELATED TO THE APHERESIS PROCEDURE AND COMPLICATIONS OF VASCULAR ACCESS ARE SHOWN IN TABLE 6. IN 22 (19.3%) PATIENTS 32 (12.6%) ADVERSE REACTIONS RELATED TO APHERESIS WERE REPORTED. FOURTEEN PATIENTS EXPERIENCED ONE REACTION, AND 6 EXPERIENCED REPEATED REACTIONS. MILD VASOVAGAL REACTIONS WERE REPORTED IN 2 PATIENTS. REACTIONS RELATED TO CITRATE TOXICITY WERE MOST OFTEN REPORTED (N = 30, 94%). THE SYMPTOMS OF CITRATE TOXICITY WERE MAINLY PARAESTHESIA AND TINGLING IN THE FACE AND EXTREMITIES. THESE REACTIONS WERE MOSTLY MILD AND TOLERATED WELL WITHOUT MEDICATION IN 22 CASES (73.3%), AND MODERATE IN 8 CASES (26.7%) IN WHICH ADDITIONAL INFUSION OF CALCIUM GLUCONATE WAS REQUIRED. CITRATE TOXICITY OCCURRED MORE FREQUENTLY IN WOMEN (N = 24, 75%). THERE WAS NO SIGNIFICANT DIFFERENCE IN THE OCCURRENCE OF ANY TYPE OF APHERESIS RELATED ADVERSE REACTIONS BETWEEN TWO GROUPS. NO LEUKAPHERESIS

  Patient problems: Paresthesia

  MAUDE report 19963499 ↗
• MalfunctionMay 30, 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 "BACTERIAL CONTAMINATION RATES IN EXTRACORPOREAL PHOTOPHERESIS" BY IRENE PAMLER, EVA RICHTER, JAMES A. HUTCHINSON, VIOLA H HNEL, ERNST HOLLER, ANDR GESSNER, RALPH BURKHARDT, AND NORBERT AHRENS A TEST FOR MICROBIAL CONTAMINATION WAS POSITIVE FOR (B)(4) OF THE CELL CONCENTRATES, WITH CENTRAL VENOUS ACCESS WAS THE MOST SIGNIFICANT RISK FACTOR FOR THE CONTAMINATION (ODDS RATIO = (B)(4)). PATIENT BLOOD SAMPLES WERE POSITIVE IN (B)(4) OF CASES, BUT NO PATIENTS BECAME SEPTIC. STAPHYLOCOCCUS SPP. WERE MOST ABUNDANT, AND PRODUCTS WITH BACTERIAL CONTAMINATION DID NOT CAUSE SIDE EFFECTS AFTER REINFUSION. THERE WERE NO SIGNIFICANT DIFFERENCES IN CONTAMINATION RATES BETWEEN INLINE AND OFFLINE ECP 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19425774 ↗
• MalfunctionMay 30, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "RETROSPECTIVE MULTICENTER STUDY OF EXTRACORPOREAL PHOTOPHERESIS IN STEROID-REFRACTORY ACUTE AND CHRONIC GRAFT-VERSUS-HOST DISEASE" BY GILLEN OARBEASCOA, MARIA LUISA LOZANO, LUISA MARIA GUERRA, CRISTINA AMUNARRIZ, CONCEPCION ANDON SAAVEDRA, JOSE MARIA GARCIA-GALA, AURORA VIEJO, NURIA REVILLA, CYNTHIA ACOSTA FLEITAS, JOSE LUIS ARROYO, EVA MARTINEZ REVUELTA, ANDREA GALEGO, DOLORES HERNANDEZ-MARAVER, MI KWON, JOSE LUIS DIEZ-MARTIN, CRISTINA PASCUAL EXTRACORPOREAL PHOTOPHERESIS (ECP) IS AN ESTABLISHED TREATMENT STRATEGY IN STEROID-REFRACTORY GRAFT-VERSUS-HOST DISEASE (GVHD). THIS STUDY¿S MAIN OBJECTIVE WAS TO ANALYZE THE CLINICAL RESPONSE AND IMPACT OF ECP THERAPY IN STEROID DOSE REDUCTION. A RETROSPECTIVE OBSERVATIONAL SERIES OF 113 PATIENTS FROM 7 TRANSPLANTATION CENTERS WAS ANALYZED. SIXTY-FIVE PATIENTS (58%) HAD ACUTE GVHD (AGVHD), AND 48 (42%) HAD CHRONIC GVHD (CGVHD). ALL ECP PROCEDURES WERE PERFORMED WITH THE OFF-LINE SYSTEM. THE MEDIAN NUMBER OF PROCEDURES UNTIL ACHIEVEMENT OF INITIAL RESPONSE WAS 3 FOR BOTH PATIENTS WITH AGVHD AND THOSE WITH CGVHD. ECP WAS THE SECOND-LINE THERAPY IN 48% OF THE AGVHD CASES AND IN 50% OF THE CGVHD CASES. 71% OF THE CASES OF A

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

  MAUDE report 19425619 ↗
• InjuryMay 30, 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 "FACTORS AFFECTING CLINICAL OUTCOMES OF CONTINUOUS AND INTERMITTENT PLASMAPHERESIS IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA" BY EIMAN A. HUSSEIN PATIENTS WERE OBSERVED FOR SEVERE AND MILD ADVERSE EVENTS (AES). AES WERE CONSIDERED SEVERE IF PATIENTS REQUIRED ADMISSION TO THE ICU. THEY WERE CATEGORIZED AS FOLLOWS: 1. CITRATE RELATED WHICH INCLUDED TINGLING, NUMBNESS, NAUSEA, VOMITING, ABDOMINAL AND CHEST PAINS. 2. HYPOTENSION WHICH WAS TREATED BY SALINE INFUSION. 3. PLASMA RELATED. 4. VENOUS ACCESS RELATED. 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: Abdominal Pain; Chest Pain; Low Blood Pressure/ Hypotension; Nausea; Numbness; Vomiting

  MAUDE report 19425231 ↗
• MalfunctionMar 27, 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 CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION PROCEDURE ON A SPECTRA OPTIA DEVICE, THE SALINE LINE CONTINUED TO DRIP. THE OPERATOR HAD PLACED A HEMOSTAT BELOW THE DRIP CHAMBER. TERUMO BCT SUPPORT ASKED THE OPERATOR TO CHECK THE ROLLER CLAMPS AND THE RED ROLLER CLAMP WAS STILL OPEN. IT WAS REPORTED THAT ABOUT 600 MLS OF NORMAL SALINE (NS) THAT WENT TO THE PATIENT. PER CALCULATIONS THE FINAL FLUID BALANCE = 146.7 % PATIENT AGE AND OUTCOME ARE NOT AVAILABLE AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hypervolemia

  MAUDE report 18988848 ↗
• InjuryNov 21, 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 THAT DURING A CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION ON A SPECTRA OPTIA DEVICE, THEY HAD PROBLEMS ESTABLISHING THE INTERFACE. PER THE CUSTOMER THERE WERE NO ALARMS. THE CUSTOMER CHANGED OUT THE 1 LITER NORMAL SALINE (NS) BAG TWO TIMES. PER THE OPERATOR THE RED AND BLUE ROLLER CLAMPS WERE CLOSED. THE PROCEDURE WAS ENDED WITH THE PATIENT RECEIVING RINSE BACK AND USING ANOTHER MACHINE FOR THE PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT HAD HYPERTENSION, TACHYCARDIA AND COMPLAINED OF SHORTNESS OF BREATH. PER THE LOCATIONS DOCTOR, THE PATIENT WAS GIVEN AMLODOPINE 5 MG PO, X 2 DOSES. PER THE CUSTOMER THE PATIENT WAS REPORTED AS STABLE. THE CUSTOMER WAS NOT ABLE TO PROVIDE PATIENT ID AND WEIGHT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE PATIENTS WEIGHT AND LOT NUMBER BUT THE CUSTOMER FAILED TO RESPOND. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 18184458 ↗
• MalfunctionOct 26, 2023Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem; Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem

  THE CUSTOMER REPORTED TO TERUMO BCT CUSTOMER SUPPORT THAT DURING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROCEDURE THEY WERE HAVING PROBLEMS STABILIZING THE INTERFACE. THE CUSTOMER LOWERED THE HCT AND AC RATIO AND THEN NOTICED THAT THE RED SALINE ROLLER CLAMP WAS OPEN AND THE NORMAL SALINE BAG WAS EMPTY. SHE REPLACED THE BAG, BUT WAS STILL UNABLE TO ESTABLISH THE INTERFACE. THE CUSTOMER REPORTED THAT THE HCT WAS 38 AND THE INTERFACE WAS AT 1/4, SO CUSTOMER SUPPORT SUGGESTED SHE LOWER THE HCT TO 32 AND AFTER A FEW MINUTES THE INTERFACE WAS IN THE CORRECT POSITION. THERE WERE CELLS IN THE COLLECT PORT SO CUSTOMER SUPPORT PROVIDED INSTRUCTIONS ON HOW TO CONTINUE WITH THE RUN BY ADJUSTING THE CP AND OPENING THE COLLECT VALVE WHEN THEY REACHED THE DESIRED COLOR. DONOR VOICED NOT COMPLAINTS, EXHIBITED NO ADVERSE REACTIONS. DONOR REMAINED BASELINE THROUGHOUT THE PROCEDURE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hypervolemia

  MAUDE report 18013220 ↗
• MalfunctionAug 17, 2023Human-Device Interface Problem; Inadequate User Interface; Insufficient Device Problem Information; Human-Device Interface Problem; Inadequate User Interface; Insufficient Device Problem Information

  THE CUSTOMER REPORTED TO TERUMO BCT CUSTOMER SUPPORT THAT AFTER CONNECTING THE PATIENT, THEY CONFIRMED THAT THE SALINE ROLL CLAMP ON THE RETURN LINE WAS HELD DURING THE PROCEDURE, BUT THE SALINE CONTINUED TO ENTER. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ESSENTIAL INFORMATION BUT THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: Hypervolemia

  MAUDE report 17565086 ↗
• InjuryAug 3, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "HOW DO WE...CONSISTENTLY PROVIDE HIGH-DOSE GRANULOCYTE PRODUCTS FOR TRANSFUSIONS IN NEUTROPENIC PATIENTS? TRANSFUSION. 2023." BY AUTHORS: BUBAR, R.,KISS, J. E.,TRIULZI, D. J.,D'ANDREA, P.,ZILICH, A.,KAPLAN, A. THERE WERE ADVERSE EVENTS THAT OCCURRED DURING GRANULOCYTE PROCEDURES THAT INCLUDED LOCAL HEMATOMA, MODERATE CITRATE REACTION, AND A BAG FAILURES THE CITRATE REACTION WAS TREATED WITH ORAL CALCIUM CARBONATE AND REDUCING THE ANTICOAGULANT TO THE DONOR. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17452050 ↗
• MalfunctionJul 20, 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 CALLED TERUMO BCT CUSTOMER SUPPORT AFTER PAUSING A PLATELET DEPLETION PROCEDURE BECAUSE THE PATIENT HAD A DROP IN BLOOD PRESSURE. THE CUSTOMER WANTED TO KNOW IF THEY COULD CONTINUE TO USE THE DISPOSABLE SET. THE CUSTOMER SAID THE PATIENT RECEIVED A BOLUS OF NORMAL SALINE BECAUSE THEIR BLOOD PRESSURE DROPPED. THE PATIENT WAS STABLE AFTER, BUT THE CUSTOMER WANTED TO CONTINUE THE RUN AND DIDN'T KNOW IF THEY COULD CONTINUE TO USE THE DISPOSABLE SET. 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: Low Blood Pressure/ Hypotension

  MAUDE report 17362141 ↗
• MalfunctionJul 13, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE CUSTOMER CALLED TERUMO BCT CUSTOMER SUPPORT BECAUSE THE NATURAL SALINE (NS) CONTINUED TO DRIP DURING A CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION. THE OPERATOR WAS USING A 1 LITER BAG OF NS AND THE TERUMO BCT CUSTOMER SUPPORT SPECIALIST ASKED IF BOTH NS ROLLER CLAMPS WERE CLOSED. THE OPERATOR DISCOVERED THAT THE RED ROLLER CLAMP WAS NOT CLOSED. THE OPERATOR CLOSED THE SALINE ROLLER CLAMP AND THE NS STOPPED DRIPPING. THE OPERATOR THEN HAD AN INTERFACE TAKING TOO LONG TO ESTABLISH ALARM. TERUMO BCT CUSTOMER SUPPORT TOLD HER TO LOWER THE HCT. THE INITIAL HCT ENTERED WAS 38. THE OPERATOR LOWERED IT DOWN TO 35. TERUMO BCT CUSTOMER SUPPORT INDICATED THAT THIS ACTION HAD DILUTED THE HCT IN THE CHANNEL. THE OPERATOR INFORMED THAT THE INTERFACE WAS ABOUT HALF OF THE CONNECTOR WHEN TERUMO BCT CUSTOMER SUPPORT HAD HER LOWER THE HCT AND THEY INSTRUCTED THAT IF SHE HAS THE ALARM AGAIN SHE MAY NEED TO LOWER THE HCT AGAIN. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hypervolemia

  MAUDE report 17319693 ↗
• MalfunctionJun 12, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IN THE JOURNAL ARTICLE " SUCCESSFUL HEMATOPOIETIC PROGENITOR CELL COLLECTION VIA APHERESIS HPC-A IN A VERY LOW WEIGHT INFANT WITH ATYPICAL TERATOID/RHABDOID TUMOR USING GRANULOCYTE COLONY STIMULATING FACTOR AND PLERIXAFOR" IT WAS REPORTED THAT A PATIENT HAD SOME TACHYCARDIA TOWARDS THE END OF THE PROCEDURE WHICH RESOLVED WITH INTRAVENOUS HYDRATION. THE REPORTED PROCEDURE WAS A SUCCESSFUL HPC-A COLLECTION ON A 4.75 KG INFANT WITH ATYPICAL TERATOID/RHABDOID TUMOR (ATRT) USING GRANULOCYTE COLONY STIMULATING FACTOR (GCSF) AND PLERIXAFOR FOR HPC MOBILIZATION. PATIENT TOLERATED THE PROCEDURE WITHOUT ANY SIGNIFICANT ADVERSE EFFECTS SUCH AS HYPOTENSION, BRADYCARDIA, OR BLEEDING SYMPTOMS. FURTHER DETAILS OF THE PATIENT AND PROCEDURE WERE NOT INCLUDED IN THE ARTICLE FOR THIS EVENT. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

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

  MAUDE report 17112492 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IN JOURNAL ARTICLE: "SYNGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION AFTER MOBILIZATION FAILURE IN AN ADOLESCENT WITH INTRACRANIAL GERM CELL TUMOR", BY SÁNCHEZ-SIERRA, N. ET AL IT WAS REPORTED THAT THE PATIENT RECEIVED HDCT BASED ON SIOP-CNS-GCT-II GUIDELINES AND A NON-MANIPULATED SYNGENEIC GRAFT. GIVEN THE CELLULARITY OF THE PRODUCT (2.4 × 106 CD34+/KG), HE RECEIVED SUBCUTANEOUS G-CSF FROM DAY+5 TO 2 DAYS AFTER REACHING THE WHITE BLOOD CELL GRAFT (DAY+9) AS WELL AS CORTICOSTEROID PROPHYLAXIS OF THE ENGRAFTMENT SYNDROME. AS MAIN COMPLICATIONS, HE DEVELOPED ESCHERICHIA COLI SEPSIS, GRADE 3 HYPEREMESIS, AND MUCOSITIS. ANTIVIRAL AND ANTIBIOTIC PROPHYLAXIS WAS DISCONTINUED 4 MONTHS AFTER SHSCT. THE PATIENT CONTINUED TREATMENT AS PLANNED WITH FOCAL PROTON BEAM RADIATION THERAPY. HE ENDED TREATMENT 8 MONTHS AFTER DIAGNOSIS AND IS CURRENTLY IN COMPLETE REMISSION. PATIENT ID AND WEIGHT ARE NOT AVAILABLE AT THIS TIME AS THEY WERE NOT INCLUDED IN THE ARTICLE FOR THIS EVENT. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Sepsis

  MAUDE report 16887541 ↗
• MalfunctionFeb 24, 2023Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem; Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem

  THE CUSTOMER REPORTED THE CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) IS STILL ESTABLISHING INTERFACE AFTER 25 MIN. THE OPERATOR ENTERED A HCT OF 36% FROM 1/12/23 AND ONLY CHECKED THE LINES TO MAKE SURE THEY WERE NOT OBSTRUCTED. CUSTOMER SUPPORT SUGGESTED TO LOWER THE HCT DOWN BY 3% AND WAIT 3-5 MIN. IF THE INTERFACE STILL WASN'T ABOUT HALF OF THE CONNECTOR IT WAS SUGGESTED TO LOWER THE HCT ANOTHER 3%. THE CUSTOMER CALLED BACK AFTER ADJUSTING THE HCT DOWN BY 8% AND SAID THE INTERFACE WAS STILL IN THE SAME POSITION. A PICTURE WAS SENT AND IT WAS MAYBE ABOUT 1/4TH OF THE CONNECTOR. IT WAS ASKED IF THE SALINE LINE ROLLER CLAMPS WERE OPEN. THE OPERATOR REALIZED THE RED ROLLER CLAMP WAS OPEN AND WAS ON THE 2ND 500 ML BAG. THE OPERATOR SAID SHE WAS CHECKED OFF TO DO THIS PROCEDURE. CUSTOMER SUPPORT EXPLAINED SHE SHOULDN'T HAVE TO CHANGE OUT THE SALINE BAG FOR THE PROCEDURE. THE HCT HAS BEEN DILUTED AND THIS IS WHY THE INTERFACE HAS NOT COME UP. THE OPERATOR REPORTED THERE WAS ABOUT 50 MLS LEFT IN THE 2ND BAG. IT WAS ESTIMATED THE 657 ML OF NS USED. CUSTOMER SUPPORT SUGGESTED SHE LOWER HCT DOWN BY 6% WHICH IS NOW AT 22%. AFTER MULTIPLE FOLLOW-UP ATTEMPTS, THE CUSTOMER DID NOT PROVIDE PA

  Patient problems: Hypervolemia

  MAUDE report 16437280 ↗
• InjuryJan 20, 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 CONFERENCE ABSTRACT, 'EXPERIÊNCIA DE UM SERVIÇO PÚBLICO DE PORTO ALEGRE-RS COM OS PRIMEIROS PACIENTES SUBMETIDOS AO TRANSPLANTE DE CÉLULAS TRONCO HEMATOPOIÉTICAS' OR "EXPERIENCE OF A PUBLIC SERVICE OF PORTO ALEGRE-RS WITH THE FIRST PATIENTS UNDERGOING TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS" WAS PUBLISHED 15OCT2022. THE ABSTRACT IS NOT IN ENGLISH AND WAS PRELIMINARILY TRANSLATED USING GOOGLE TRANSLATE. THE ARTICLE, 'EXPERIENCE OF A PUBLIC SERVICE IN PORTO ALEGRE-RS WITH THE FIRST PATIENTS UNDERGOING HEMATOPOIETIC STEM CELL TRANSPLANTATION' DISCUSSES A DESCRIPTIVE STUDY ON PATIENTS UNDERGOING HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT). PER THE ARTICLE, THE MOST FREQUENT COMPLICATIONS OF DONOR BEFORE THE PROCEDURE WERE MUCOSITIS (GRADE 1, N = 2; GRADE 2, N=4; GRADE 3, N = 1; CTCAE V5.0), FEBRILE NEUTROPENIA (GRADE 3, N = 8; CTCAE V5.0) AND DIARRHEA (GRADE 1, N = 5, GRADE 2, N = 3; CTCAE V5.0). ONE PATIENT HAD SEPTIC SHOCK, BEING TRANSFERRED INJURED TO THE INTENSIVE CARE UNIT, WITH RECOVERY AND RETURN TO THE INPATIENT UNIT IN 4 DAYS. THE ARTICLE DOES NOT PROVIDE INDIVIDUAL PATIENT INFORMATION, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY OF EVENTS. THIS IS A JOURN

  Patient problems: Diarrhea; Fever; Septic Shock

  MAUDE report 16216374 ↗
• InjuryJan 10, 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 JOURNAL ARTICLE, 'LONG-TERM OUTCOMES AND SAFETY TRENDS OF AUTOLOGOUS STEM-CELL TRANSPLANTATION IN NON-HODGKIN LYMPHOMA: A REPORT FROM A TERTIARY CARE CENTER IN INDIA', DESCRIBES A STUDY ON AUTOLOGOUS STEM-CELL TRANSPLANTATION (ASCT) IN NON-HODGKIN LYMPHOMA (NHL) ADULT PATIENTS AUTOGRAFTED BETWEEN JANUARY 1, 2002, AND DECEMBER 15, 2020. PER THE ARTICLE, ALL PATIENTS DEVELOPED FEBRILE NEUTROPENIA AT A MEDIAN OF 4 AFTER TRANSPLANT. MICROBIOLOGICAL EVIDENCE OF INFECTION WAS AVAILABLE IN 26 (32.5%) PATIENTS OVERALL: GRAM-NEGATIVE BACTERIA IN 17 (21.2%), GRAM-POSITIVE ISOLATES IN SIX (7.5%), AND MIXED ORGANISM GROWTH IN THREE (3.7%) PATIENTS. A MEDIAN OF 5 (IQR, 2-8) ANTIBIOTICS WERE USED FOR A DURATION OF 13 DAYS (MEDIAN, 7-37) DAYS. FORTY-FOUR (55.0%) PATIENTS REQUIRED THERAPEUTIC ANTIFUNGALS BEGINNING ON DAY 8 (MEDIAN, IQR 5- 13) AND AMPHOTERICIN B WAS MOST COMMONLY USED (54.5%). PATIENTS IN GROUP B USED FEWER NUMBERS (4 V 5, P = .004) AND DURATIONS (11 V 16 DAYS, P = .01) OF ANTIBIOTICS, BUT THERAPEUTIC ANTIFUNGAL USE WAS NOT DIFFERENT AMONG THE STUDY GROUPS. THE MOST COMMON GRADE 3 OR 4 REGIMEN-RELATED TOXICITIES WERE MUCOSITIS, DIARRHEA AND VOMITING. OVERALL, NINE (11.2%) PATIE

  Patient problems: Bacterial Infection; Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 16131508 ↗
• DeathNov 28, 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 A PATIENT DIAGNOSED WITH RIGHT CEREBELLAR HEMORRHAGE WITH OBSTRUCTIVE HYDROCEPHALUS, WITH NEWLY DIAGNOSED CHRONIC MYELOID LEUKEMIA (CML) IN BLAST CRISIS, WAS UNDERGOING A WHITE BLOOD CELL DEPLETION (WBCD) PROCEDURE, STARTING TIME 2100. TOTAL VOLUME REMOVED: 1493ML (1.5 TBV PROCESSED). PATIENT'S VITAL SIGNS WERE CHECKED EVERY 15 MINS, WITH BP 146/91 MMHG AND PULSE 93 BPM @ 2120. THE PATIENT COMPLAINED OF HEADACHE ON AND OFF, IV MORPHINE 0.8ML WAS ADMINISTERED. IV CALCIUM GLUCONATE WAS GIVEN DURING THE WBCD PROCEDURE. PROCEDURE COMPLETED @ 2340 AND PATIENT WAS STABLE. ON (B)(6) 2022 @ 0000, PATIENT WAS GIVEN PLATELET TRANSFUSION AFTER BEING SENT TO THE WARD. DURING 4TH PLATELET TRANSFUSION, PATIENT COMPLAINED OF SEVERE HEADACHE AND NURSE INFORMED DOCTOR ON-CALL @ 0015. PATIENT COLLAPSED @ 0025. CPR COMMENCED @ 0030 AND PATIENT RETURN OF SPONTANEOUS CIRCULATION @ 0050. PATIENT INTUBATED AND SUPPORTED WITH SINGLE INOTROPE - IV NORADRENALINE. PATIENT'S INR STILL PROLONGED AFTER GIVEN 4 UNITS CRYOPRECIPITATE + 4 UNITS FFP, POOR PROGNOSIS - REVIEWED BY DOCTOR @0400 NO BREATHING EFFORT AND PATIENT'S FAMILY WISHED FOR DNR. PRONOUNCED DEATH @0905. PER THE CUSTOMER,

  Patient problems: Cardiac Arrest

  MAUDE report 15871168 ↗
• MalfunctionOct 7, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Device Handling Problem

  FOR AN MONONUCLEAR CELL COLLECTION PROCEDURE, THE PATIENT'S WEIGHT WAS INADVERTENTLY ENTERED AS 143KG. PATIENT'S ACTUAL WEIGHT IS 63KG. THIS WAS NOTED AT APPROXIMATELY 112 MINUTES INTO THE PROCEDURE. SYSTEM CALCULATED TOTAL BLOOD VOLUME (TBV): 6426ML THEN LOWERED TO 3813ML AT 112 MINUTES. REPORTED TOTAL AMOUNT OF AC DELIVERED: 1666ML. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT'S IDENTIFIER. THE PATIENT IS STABLE. FROM THE PATIENT'S RECORD: 1706ML TOTAL AC; 43 OF AC IN COLLECT BAG; 1666ML GIVEN TO PATIENT. PATIENT DID DEVELOP TINGLING, BUT NO OTHER SYMPTOMS. CA+CL 40.8MEQ IV, 50ML/HOUR GIVEN, PER STANDING ORDER. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15566191 ↗