MAUDE Adverse Event Report: TERUMO BCT COBE 2991; 2991 BLOOD CELL PROCESSOR

Catalog Number 90819

Device Problems Difficult to Open or Close (2921); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: in lieu of the disposable set, the customer supplied two images of the reported incident to aid the investigation.The first image clearly displays the twisted tubing immediately proximal to the ceramic rotating seal.The twist was located just under the orange lower collar between the rotating seal and the cell processing bag.The second image displays the rotating seal and processing bag, from this image the presence of fluid throughout the processing bag and rotating seal inlet tubing can be confirmed.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that during processing on the cobe 2991 set, they had difficulty twisting the tubing between the hexagonal piece and the collection bag to open the cobe.The product was transferred back to a new set and they had to delay distribution of the product.Per the customer, the collected product was positive for hepatitis-c antibodies.The presence of the antibodies in the plasma was already known to the customer, so the product was not tested for the virus.All other micro-organism tests were negative.The customer declined to provide patient identifier, age, and sex.Patient weight and outcome are not available at this time.The 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 b.5, and h.6.Corrected information is provided in a.1.Investigation is in process.A follow up report will be provided.

Event Description

Bacterial testing for the plasma product was negative for aerobic and anaerobic organisms after 10 days of incubation.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.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, d.4, h.6 and h.10.Corrected information is provided in a.1.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Based on the customer's statement and the serology report, the patient's exposure to hepatitis c virus was a pre-existing condition.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the statement in the laboratory report, as well as the date of the serology test, the positive result for the hepatitis c virus (hcv) antibodies was related to the patient's pre-existing medical condition.A definitive root cause for the twisted stem tube could not be determined.Possible causes include but are not limited to: - a misaligned seal weight could cause the rotating assembly to run at an angle to the tubing.As the centrifuge spins, this would create pressure at the tubing, potentially causing twisting.- pausing or reversing of the centrifuge.Any time the centrifuge stops or changes direction during a procedure, there is some possibility that the fluid between the ceramic surfaces will bind them together.This could be aggravated by a misaligned seal weight.This type of failure is not typically observed for short pauses or turns and so the guideline provided to customers is that the centrifuge should be re-started within 3 minutes.

Event Description

Pursuant to eu mdr personal data protection laws, patient information is not available from the customer.

• Brand Name: COBE 2991
• Type of Device: 2991 BLOOD CELL PROCESSOR
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10483285
• MDR Text Key: 210623104
• Report Number: 1722028-2020-00422
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 90819
• Device Lot Number: 12C15003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other