MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA WHITE BLOOD CELL SET

Model Number	70600
Health Effect - Clinical Code	Death (1802)
Date of Event	01/01/2014
Type of Reportable Event	Death
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Article citation: ceppi f, rivers j, annesley c, et al.Lymphocyte apheresis for chimeric antigen receptor t-cell manufacturing in children and young adults with leukemia and neuroblastoma.Transfusion 2018;58:1414-20.Article may be retrieved online: https://onlinelibrary.Wiley.Com/doi/full/10.1111/trf.14569 investigation is in process.A follow-up report will be provided.
Event or Problem Description
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 at this time.This report is being filed due to patient death, though at this time, there is no allegation that the device caused or contributed to the event.The disposable set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: based on the clinical and investigation findings, the cobe spectra performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused these adverse events.All complications experienced within this study are well-known adverse events identified in the product labeling for the cobe spectra device.Root cause: the patient death is believed to be related to the patient's pre-existing disease state.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b5 and h10.Investigation: study results: ninety-nine patients (ages 1.3-25.7 years) and 102 apheresis events were available for analysis.Patients underwent apheresis at a variety of absolute lymphocyte cell counts, with a median absolute lymphocyte count of 944 cells/ll (range, 142-6944 cells/ll).Twenty-two patients (21.6%) had absolute lymphocyte counts less than 500 cells/ll.The mononuclear cell target was obtained in 100% of all apheresis harvests, and chimeric antigen receptor t-cell production was possible from the majority of collections (94%).Mononuclear cell collection efficiency was 65.4%, and t- lymphocyte collection efficiency was 83.4%.Ten patients (9.8%) presented with minor adverse events during the 102 apheresis procedures, with one exception of a severe allergy.Study conclusions: mononuclear cell apheresis for chimeric antigen receptor t-cell therapy is well tolerated and safe, and it is possible to obtain an adequate quantity of cd31 lymphocytes for chimeric antigen receptor t-cell manufacturing in heavily pretreated patients who have low lymphocyte counts.In one patient with leukemia in the (b)(6) study, car t-cell manufacturing was aborted when the patient died 10 days after apheresis.There is no evidence to indicate that the cobe spectra device caused or contributed to the death of the patient.The disposable set was not available for return.Since 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, the lots numbers are unknown, therefore, a dhr search could not be conducted for the reported incident.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.
Event or Problem Description
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).A request for specific patient information is not feasible.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Common Device Name: COBE SPECTRA WHITE BLOOD CELL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10163972
• Report Number: 1722028-2020-00302
• Device Sequence Number: 14116692
• Product Code: GKT
• UDI-Device Identifier: 05020583706002
• UDI-Public: 05020583706002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: BK080035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 70600
• Device Catalogue Number: 70600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 06/29/2022; 07/19/2022
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/15/2022; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown