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

Catalog Number 90819

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a disposable history search found no other reports of a similar issue associated with this lot worldwide.Investigation is in process.A follow-up report will be provided.

Event Description

Medwatch reprt # mw5099119 was received.In the report, the customer stated, "upon debulking a marrow on the cobe cell washer, a line became loose and disconnected from the cobe bag.We opened another bag of the same lot and tried to re-create the event, but couldn't get the line to loosen or pull away from the bag.We think it was a faulty bag initially." the customer indicated on the medwatch report that the patient required medical intervention as a result of the incident.The medical intervention that was required was not specified.Patient information is unknown per mw-5099119.The disposable set is not available for return because it was discarded by the customer.

Event Description

The customer did not respond to multiple attempts to obtain further event details or patient information.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.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.

Manufacturer Narrative

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.It was confrimed that the incident was a leak only with no patient injury or medical intervention required.The customer provided photographs of the reported event in lieu of the disposable set.The photos confirmed a leak at the bond socket/manifold connection via detached purple striped tubing.Analysis of image 1 shows a clear leak path at one side of the the tubing while still partially connected.Image 2 confirms the leak from complete tubing detachment.The video documents attempts by the customer to recreate the leak issue on a second tubing set.No leak or break in the tubing bond could be verified on the second set.Root cause: based on the analysis of the returned photographs, the root cause is believed to be related to the manufacturing process.Possible scenarios within the bonding process that caused the leak include but are not limited to: - inadequate contact of the tubing with the bond socket after solvent application - insufficient application of solvent to the tubing - inadequate insertion of the tube into the bond socket.Correction: information regarding failures of this type is regularly shared with the relevant manufacturing teams.

Event Description

Per the customer, the patient graft was successful, the leak was described as ¿minor¿, i.E.No significant loss of bone marrow product.There were no complications for the patient.The reporting physician confirmed that the leak started as a slow leak via a bond void at the tubing manifold, before the tubing came away completely.The doctor indicated they were concerned at the time about product sterility/contamination due to open bond socket.The serology tests from the lab were returned negative.The medical intervention was described by the doctor as ¿a short delay while the product was transferred into another bag¿.The customer declined to provide further patient information.

• Brand Name: COBE 2991
• Type of Device: BCP 2991
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11664172
• MDR Text Key: 245349410
• Report Number: 1722028-2021-00152
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 90819
• Device Lot Number: 09D15004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention