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

Model Number 70600

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2014

Event Type  Injury  

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 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.One product was unacceptable due to infection.The patient underwent a second apheresis because of concerns about product contamination when the patient had a positive blood culture result after collection.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.The disposable set is not available for return because it was discarded by the customer.

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 authors stated that "one underwent a second apheresis because of concerns about product contamination when the patient had a positive blood culture result after collection".Based on this information, the patient had active infection at the time of the procedure.

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 (b)(4) cells/ll (range, 142-6944 cells/ll).Twenty-two patients (21.6%) had absolute lymphocyte counts less than (b)(4) 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 plat-02 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 bacteria could not be identified because the author did not indicate what culture was positive for.Per internal sterility lab documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event 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 nct02028455 (plat-02) or nct02311621 (engineered neuroblastoma cellular immunotherapy [encit]-01).A request for specific patient iformation is not feasible.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: 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: 10163960
• MDR Text Key: 200623756
• Report Number: 1722028-2020-00303
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583706002
• UDI-Public: 05020583706002
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 06/29/2022; 07/19/2022
• Supplement Dates FDA Received: 07/15/2022; 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other