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

Catalog Number 000000000000090819

Device Problems Device Alarm System (1012); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

The customer reported a leak that occured during bone marrow processing, after plasma depletion, when they started to collect the buffy coat in the collect bag.Blood appeared on the rotating seal and at the connection of the lines with the processing bag.Per the customer, 10-15 ml of buffy coat were lost.There were no alarms.The bone marrow was transferred to another set and processed again.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable set will not be returned, because the customer discarded it.This report is being filed in response to the customer filing a sae report.

Manufacturer Narrative

Investigation is in-process a follow-up report will be provided.

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.Root cause: a definitive root cause could not be determined.It is possible that the leak occurred was a result a manufacturing defect or procedural error.The seals can become seized due to different causes.If the ceramic seal has not been properly manufactured, its shape or surface can have an irregularity and thus the potential for them to seize together.If the procedure was started without fluid above the rotating seal or if the processing procedure is paused for more than 3 minutes without the centrifuge spinning, the seals can become stuck together.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately.

• Brand Name: COBE 2991
• Type of Device: COBE 2991 BLOOD CELL PROCESSING SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: robbin crafe ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392282
• MDR Report Key: 4358433
• MDR Text Key: 5179908
• Report Number: 1722028-2014-00516
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 000000000000090819
• Device Lot Number: 07V15002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other