MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA WHITE BLOOD CELL SET, CLOSED

Catalog Number 000000000000070620

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/02/2014

Event Type  malfunction  

Event Description

The customer reported that after a mononuclear cell (mnc) collection procedure, there was a leak by the 'y' connector from the plasma line and the mnc product bag.She had finished transferring the plasma into the mnc bag and she clamped the bag and then stripped the line and the line came apart from the y.No medical intervention was necessary for this event.The patient is in stable condition.The product was sent to their customer for sterility testing to determine if it would be used.The customer did not have final sterility test results, but were told by the second party that the product was used.The customer declined to provide patient identifier, age, and weight information.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to the potential for injury if the same failure were to reoccur.

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: this disposable set was unavailable for specific root cause analysis.A definitive root cause for the leak could not be determined.Additionally, the customer was not able to confirm sterility results but did confirm that the product was used.Based on customer statements,possible causes for the leak include but are not limited to insufficient solvent at the y-connector bond during the manufacturing process or build up of pressure during the stripping process because the line was clamped.

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 SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET, CLOSED
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4358312
• MDR Text Key: 21724771
• Report Number: 1722028-2014-00513
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

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: 06/01/2016
• Device Catalogue Number: 000000000000070620
• Device Lot Number: 06W15237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• 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