COBE® Spectra 70600Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05020583706002), received between Jun 17, 2020 and Jun 25, 2024 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "NOVEL ADJUVANT DENDRITIC CELL THERAPY WITH TRANSFECTION OF HEAT-SHOCK PROTEIN 70 MESSENGER RNA FOR PATIENTS WITH HEPATOCELLULAR CARCINOMA: A PHASE I/II PROSPECTIVE RANDOMIZED CONTROLLED CLINICAL TRIAL". BY MATSUI, H. M., HAZAMA, S., NAKAJIMA, M., XU, M., MATSUKUMA, S., TOKUMITSU, Y., SHINDO, Y., TOMOCHIKA, S., YOSHIDA, S., IIDA, M., SUZUKI, N., TAKEDA, S., YOSHINO, S., UENO, T., OKA, M., NAGANO, H.. AMONG THE SAFETY POPULATION COHORT, AES WERE REPORTED IN 39 PATIENTS (88.6%); OF THESE, 35 PATIENTS (79.5%) HAD MILD TO MODERATE AES (GRADE 1 OR 2). THE FREQUENCY OF ALL AES BETWEEN THE TWO GROUPS WAS COMPARABLE. MOST OF THESE AES WERE AFECTED BY BACKGROUND LIVER DISEASE. IN THE DC GROUP, TWO PATIENTS HAD GRADE 3 ANEMIA AND TWO PATIENTS HAD GRADE 3 THROMBOCYTOPENIA. HOWEVER, THERE WAS NO SIGNIFCANT CHANGE IN LIVER FUNCTION IN THESE PATIENTS. FURTHERMORE, ALTHOUGH THESE PATIENTS MET THE INCLUSION CRITERIA, ANEMIA AND THROMBOCYTOPENIA WERE MORE PROMINENT BEFORE DC TREATMENT THAN IN OTHER CASES. SO, THESE AES WERE UNLIKELY TO BE ASSOCIATED WITH DC THERAPY AND LIKELY TO BE RELATED TO LIVER CIRRHOSIS OR SPLENOMEGALY, WHICH DEVELOPED DURING THE CHRONIC COURSE OF THE DISEA

  Patient problems: Anemia; Fever; Itching Sensation; No Clinical Signs, Symptoms or Conditions; Rash; Thrombocytopenia

  MAUDE report 19606505 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem

  THE DISPOSABLE SET WAS NOT AVAILABLE FOR RETURN. SINCE THIS WAS A STUDY TO EVALUATE THE USE OF THE SPECTRA OPTIA CMNC COLLECTION PROCEDURE COMPARED TO COBE SPECTRA DURING THIRTY-SIX CONSECUTIVE LEUKAPHERESIS PROCEDURES ON 18 PATIENTS PERFORMED BETWEEN (B)(6) 2016, THE LOT NUMBERS ARE UNKNOWN.

  Patient problems: Electrolyte Imbalance; Low Blood Pressure/ Hypotension

  MAUDE report 10420407 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem

  THIS WAS A RETROSPECTIVE REVIEW OF CLINICAL TRIALS INTO THE PRODUCTION OF CAR T CELLS FROM MNC COLLECTIONS PERFORMED ON COBE SPECTRA BETWEEN JULY 1, 2012 AND JANUARY 31, 2016, INVOLVING 71 PEDIATRIC AND YOUNG ADULT PATIENTS AGED 4 TO 30 YEARS. THE AVERAGE PATIENT AGE WAS 14.9 YEARS OLD. THE MAJORITY WERE MALE AND THE AVERAGE PATIENT WEIGHT 48.0 KG. 58 PATIENTS WERE DIAGNOSED WITH ALL AND 13 PATIENTS WITH "SOLID TUMOR" (INCLUDES: OSTEOSARCOMA, NEUROBLASTOMA, DIFFUSE LARGE B CELL LYMPHOMA). A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Reaction

  MAUDE report 10165382 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  THIS WAS A RETROSPECTIVE REVIEW OF CLINICAL TRIALS INTO THE PRODUCTION OF CAR T CELLS FROM MNC COLLECTIONS PERFORMED ON COBE SPECTRA BETWEEN JULY 1, 2012 AND JANUARY 31, 2016, INVOLVING 71 PEDIATRIC AND YOUNG ADULT PATIENTS AGED 4 TO 30 YEARS. THE AVERAGE PATIENT AGE WAS 14.9 YEARS OLD. THE MAJORITY WERE MALE AND THE AVERAGE PATIENT WEIGHT 48.0 KG. 58 PATIENTS WERE DIAGNOSED WITH ALL AND 13 PATIENTS WITH "SOLID TUMOR" (INCLUDES: OSTEOSARCOMA, NEUROBLASTOMA, DIFFUSE LARGE B CELL LYMPHOMA). A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10165378 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem

  THIS WAS A RETROSPECTIVE CLINICAL STUDY TO EVALUATE MONONUCLEAR CELL APHERESIS FOR CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY BETWEEN (B)(6) 2014 AND (B)(6) 2017, INVOLVING 99 PATIENTS, AGES 1 TO 26 YEARS WHO WEIGHED GREATER THAN 10 KG AND WERE ENROLLED IN (B)(6) (PLAT-02) OR (B)(6) (ENGINEERED NEUROBLASTOMA CELLULAR IMMUNOTHERAPY [ENCIT]-01). A REQUEST FOR SPECIFIC PATIENT IFORMATION IS NOT FEASIBLE.

  Patient problems: Reaction

  MAUDE report 10163982 ↗
• DeathJun 17, 2020Adverse Event Without Identified Device or Use Problem

  CEPPI, ET.AL. (2018) RECENTLY PUBLISHED THEIR EXPERIENCE WITH CAR T-CELL COLLECTION AND PROCESSING AT THE SEATTLE CHILDREN¿S HOSPITAL AND RESEARCH INSTITUTE AMONG 99 HEAVILY PRETREATED PEDIATRIC AND YOUNG ADULT PATIENTS (AGED 1.3¿25.7 YEARS) WITH ACUTE LYMPHOBLASTIC LEUKEMIA (ALL), NON-HODGKIN LYMPHOMA, AND NEUROBLASTOMA. THIS STUDY DEMONSTRATED A 100% SUCCESS RATE IN ACHIEVING THE TOTAL MNC COLLECTION TARGET OF 1× 10^9 CELLS/KG. THIS STUDY ALSO EXCLUSIVELY USED THE COBE SPECTRA INSTRUMENT FOR COLLECTIONS. THE AVERAGE LYMPHOCYTE CE2 VALUES FOR THEIR COLLECTIONS WAS 83.4%, AND THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN PRODUCTS COLLECTED FROM CHILDREN WITH ALL (86.7%) COMPARED TO PRODUCTS FROM CHILDREN WITH NEUROBLASTOMA (68.8%). ONLY 96 (94%) OF THESE PRODUCTS YIELDED ADEQUATE CAR T CELLS. AMONG THE SIX INSUFFICIENT CAR T PRODUCTS, ONE WAS CANCELED DUE TO PATIENT DEATH. THE PATIENT DIED 10 DAYS AFTER APHERESIS. 102 APHERESIS COLLECTIONS ON 99 PATIENTS USING THE COBE SPECTRA MONONUCLEAR CELL PROGRAM FOR COLLECTION OF T CELLS FOR CAR-T CELL PRODUCTION. LYMPHOCYTE HARVEST FOR ALL PATIENTS WAS PERFORMED BETWEEN JANUARY 1, 2014, AND JULY 31, 2017. PATIENT INFORMATION IS NOT AVAILABLE A

  Patient problems: Death

  MAUDE report 10163972 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem

  THIS WAS A RETROSPECTIVE CLINICAL STUDY TO EVALUATE MONONUCLEAR CELL APHERESIS FOR CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY BETWEEN (B)(6) 2014 AND (B)(6) 2017, INVOLVING 99 PATIENTS, AGES 1 TO 26 YEARS WHO WEIGHED GREATER THAN 10 KG AND WERE ENROLLED IN NCT02028455 (PLAT-02) OR NCT02311621 (ENGINEERED NEUROBLASTOMA CELLULAR IMMUNOTHERAPY [ENCIT]-01). A REQUEST FOR SPECIFIC PATIENT IFORMATION IS NOT FEASIBLE.

  Patient problems: Unspecified Infection

  MAUDE report 10163960 ↗