MAUDE Adverse Event Report: TERUMO BCT QUANTUM; QUANTUM CELL EXPANSION SET

Model Number	21012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed to provide additional information.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
During follow-up with the customer, it was reported that after testing, the species that were isolated were staphylococcus epidermidis and staphylococcus capitis.
Additional Manufacturer Narrative
Investigation: per the customer, they have had other runs with the same lot number which have not resulted in contamination, but wanted to confirm with terumo bct to determine if there have been any other sources of the contamination from sampling of the reagents that feed into the set.The customer reached out to tbct to inquire how it might be possible to get contamination as it is a closed system with filters that should prevent contaminants from entering.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported contamination inside the quantum disposables set after several days of processing of the product.Per the customer, the source of the contamination is unknown, but may have introduced by them during normal processing procedure.The customer performed testing on all of the reagents attached to the sets, but all tests have shown them to be sterile.It is unknown at this time if the unit was transfused.Patient information and outcome are unknown at this time.The disposable set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: a disposable lot query search was performed for lot 05c9101 and no similar reported occurrences have been received.The customer confirmed sterility testing all the reagents involved and the results were negative.Based on the sterility assurance system employed at terumo bct, the disposable device is not the source of the bacterial contamination.Investigation is in process.A follow up report will be provided.
Event or Problem Description
There was not a transfusion recipient or patient involved at the time of this incident, therefore no patient information is reasonably known at the time of the event.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.All quality and sterility labs passed.Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
Investigation : the customer submitted three photographs in lieu of the disposable sets to supplement the investigation.The shared photographs confirmed contamination was evident in the ic circulation loop (bioreactor ic outlet) and a pressure sensor.The ph indicator in the fluid present in the ec circulation loop appeared to be neutral.Per literature review, staphylococci are common bacterial colonizers of the skin and mucous membranes of humans and other mammals.S.Epidermidis in particular is the most frequently isolated species from human epithelia.It colonizes predominantly the axillae, head, and nares.As part of the human epithelial microflora, s.Epidermidis usually has a benign relationship with its host.In addition to the abundance of s.Epidermidis on the skin, this high frequency is likely due to elaborate mechanisms to colonize catheter surfaces.Furthermore, s.Epidermidis may be involved in prosthetic joint, vascular graft, surgical site, central nervous system shunt, and cardiac device infections.Otto m.Staphylococcus epidermidis--the 'accidental' pathogen.Nat rev microbiol.2009;7(8):555-567.Doi:10.1038/nrmicro2182 per internal laboratory documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

• Brand Name: QUANTUM
• Common Device Name: QUANTUM CELL EXPANSION SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9526155
• Report Number: 1722028-2019-00444
• Device Sequence Number: 13557621
• Product Code: KJF
• UDI-Device Identifier: 05020583210127
• UDI-Public: 05020583210127
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: 21012
• Device Catalogue Number: 21012
• Device Lot Number: 04C9103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/10/2020; 12/03/2020; 04/08/2021; 05/06/2021
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/21/2020; 12/21/2020; 04/08/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other