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

Catalog Number 90819

Device Problems Break (1069); Fluid/Blood Leak (1250); Leak/Splash (1354); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: terumo bct received one round bag, manifold and associated tubing from a used 2991 set for investigation.Visual inspection confirmed the set was drained of fluid.No kinks, leaks, occlusions or damaged components were identified.The rotating seal was functional.The spike was absent from the porting hub at the end of the green tubing line.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that while the operator was removing the glucose bag from the hooks of the device, a leak was observed on her glove.The operator check under the hooks and noticed that the green tubing line was severed and the product bag was disconnected from the disposable set.The customer is alleging a possible bacterial contamination of the product.The patient was transfused with cells and bacteriological control testing was given to the patient and awaiting test results.Patient information and outcome are not available at this time.

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.Test results were received from the customer indicating negative results for microbial contamination.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.The leaking components were not returned with the rest of the set.Possible causes 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/over the bond socket.

Event Description

Due to eu personal data protection laws, the patient information is not available from thecustomer.

• Brand Name: COBE 2991
• Type of Device: COBE 2991 BLOOD CELL PROCESSING SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6472980
• MDR Text Key: 72559152
• Report Number: 1722028-2017-00136
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 90819
• Device Lot Number: 04Z15002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• 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