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

Catalog Number 90819

Device Problem Leak/Splash (1354)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the machine involved was placed 'out of service' by the customer until decontamination by boi cleaning could occur, which was scheduled for (b)(6) 2016.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that while setting up a disposable set for hematopoietic stem cells(hsc) for autologous use, the hsc product began to leak from the area where the tubing connects to the disposable set.The operator immediately saw the leak and was able to change the disposable set with a sterile product transfer to a new disposable set.The customer is alleging a possible bacterial contamination of the product.The patient was transfused the cells and they have initiated increased patient monitoring for signs of bacteremia and patient monitoring for the release of aplasia.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable set is not available for return, because it was discarded by the customer.

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.The disposable set was unavailable for return, however, a photograph of the set was provided by the customer.Upon photographic inspection, it confirmed that the processing bag central port connector was not properly welded into the bag, which is a manufacturing assembly error.Root cause: no system-related root cause for the risk of bacterial contamination was identified,as positive pressure leaks do not typically introduce bacteria into the disposables set.Although the customer indicated that one of the possible consequences of the leak was a risk of bacterial contamination of the product, they did not perform bacterial testing.The customer also indicated that the operator achieved sterile transfer of the product to a new disposable set.The root cause of the leak from the 2991 processing bag was an un-welded center port which issued to bond the tubing that connects to the ceramic seal.The inadequate weld was due to operator error during manufacture of the bag.Correction: disposables manufacturing staff were made aware of the misassembly and retrained to the appropriate procedures.

• Brand Name: COBE 2991
• Type of Device: COBE 2991 BLOOD CELL PROCESSING SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5745258
• MDR Text Key: 48926686
• Report Number: 1722028-2016-00393
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 90819
• Device Lot Number: 01Z15004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other