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

Catalog Number 90819

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemolysis (1886)

Event Date 08/09/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: fluid used during the deglycing procedure were 150ml of 12% nacl, 1000ml of 1.6% nacl and 1000ml of 0.9% nacl with 0.2% dextrose.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they observed hemolysis in a unit of red blood cells (rbcs) during the final cycle of a deglycing procedure.During the 6th cycle of the procedure, they determined that there was hemolysis using a haemonetics free hemoglobin visual comparator card.A plasma free hemoglobin test was not performed.The unit was discarded.There was not a transfusion recipient or patient involved at the time of the rbc unit processing, therefore no patient information is reasonably known at the time of the event.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a service call was placed and a machine was check out was performed.The device was operating as designed.The centrifuge speed was found to be out of tolerance and was adjusted back to the correct specification.The speed was reading around 2950 rpm when set at 3000 rpm.Terumo bct engineer stated that this would result in potential yield issues and would take the process longer to complete but it would not lead to hemolysis.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.Possible causes for the hemolysis include but are not limited to storage or handling for the frozen rbc unit.

• Brand Name: COBE 2991
• Type of Device: COBE 2991 BLOOD CELL PROCESSING SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5057311
• MDR Text Key: 25887255
• Report Number: 1722028-2015-00511
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/11/2015

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: 11/01/2016
• Device Catalogue Number: 90819
• Device Lot Number: 11W15004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2015
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• 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