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

Catalog Number 000000000000090819

Device Problems Break (1069); Unintended Ejection (1234); Fluid/Blood Leak (1250)

Patient Problems Exposure to Body Fluids (1745); Venipuncture (2129)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

The customer reported that during the procedure, the joint broke between the round bag and the tubing.The blood sprayed the operator's face and some blood got in her mouth and eyes.Per the customer, she was recommended to see a physician at the customer's site and she is currently under serological monitoring.Due to eu personal data protection laws, the patient (operator) information is not available from the customer.Terumo bct is awaiting return of the disposable set for evaluation.This report is being filed due to the potential for serious injury if the same failure were tore occur.

Event Description

The serology test result was (b)(6).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: the disposable set was returned for investigation.Visual inspection showed the stem tube was disconnected below the rotating seal.The tube was not twisted and the ceramic seal was seized.A service call for cleaning and preventive maintenance (pm) was conducted.No issues were found during the check.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A review of this lot shows no other similar complaints for leaks from the rotating seal.Root cause : the disposable set leaked because the stem tube disconnected below the rotating seal.A definitive root cause for the seized ceramic seal and stem tube disconnection is undetermined.Possible causes include but are not limited to:- the operator stopping the centrifuge for greater than 3 minutes.The ceramic seals require blood to act as a lubricant to prevent seizing.If the blood dries on the ceramic seals, then the blood can act as an adhesive and cause seizing upon centrifuge re-start.-if the weight is placed unevenly or the guide posts are not clean, then the weights cannot move smoothly up and down.This can cause excessive pressure to be exerted on the ceramic seals.Excessive pressure on the ceramic seals can cause them to become seized.- if the operator has pressed on the seal weight during the procedure then this excessive downward force can cause seizing to occur.

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.

• Brand Name: COBE 2991
• Type of Device: COBE 2991 BLOOD CELL PROCESSING SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4255639
• MDR Text Key: 4992913
• Report Number: 1722028-2014-00459
• 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,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: 000000000000090819
• Device Lot Number: 02W15001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2014
• 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