MAUDE Adverse Event Report: TERUMO BCT COBE 2991; BCP 2991

Catalog Number 90819

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); Insufficient Information (4580)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a positive bacterial culture on a washed red blood cell (rbc) product.The organism identified was bacillus species, not anthracis and curtibacterium acnes.The product was washed on (b)(6) 2020 and sent for gram stain and culture.The initial gram stain was "no organisms seen" on (b)(6) 2020, the culture of washed rbc unit first tested positive for gram positive rod.Unit id: (b)(6).It is unknown at this time if the product was transfused to a patient.The disposable set is not available for return because it was discarded by the customer.

Event Description

According to the customer, the product was discarded and not transfused.There was not a transfusion recipient or patient involved with this incident, therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

This report is being filed to provide corrected information in a.1, and additional information in b.5, e.3, h.6, and h.10 investigation: a disposable history search indicated there were no other reported occurrences of microbial contamination on this lot worldwide.The customer reported that the culture was positive for bacillus spp and cutibacterium acnes.Per literature review, bacillus organisms are widely distributed in the environment although the primary habitat is the soil.These organisms are usually found in decaying organic matter, dust, vegetable, water, and some species are part of the normal flora.In the clinical setting, outbreaks and pseudo epidemic have been traced to contaminated ventilator equipment, disinfectant (ethyl alcohol), hospital linen and dialysis equipment.Cutibacterium acnes is a bacterium associated with skin infections.It is a gram-positive, non-spore forming, and anaerobic bacillus.C.Acnes mainly colonizes hair follicles of the upper body, including the head, neck, shoulders, and axilla.It predominantly resides on the skin and in the sebaceous glands associated with hair follicles.Cutibacterium acnes is the primary cause of shoulder surgery infections.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: COBE 2991
• Type of Device: BCP 2991
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10642366
• MDR Text Key: 211518647
• Report Number: 1722028-2020-00460
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 90819
• Device Lot Number: 05D15001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other