MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA TPE SET

Catalog Number 70500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that an operator was exposed to a patient's plasma, which had leaked from the remove bag near the completion of a therapeutic plasma exchange (tpe).The operator was not wearing gloves at the time of exposure, and had a small healing cut on his hand.The operator was sent to the employee health nurse, but was not tested for any viral markers, since the patient's are negative.The customer declined to provide the patient (operator's) age and weight.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 for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause : a definitive root cause of the leak could not be determined as the set was not available for return.Possible causes include but are not limited to: an error in the radio frequency (rf) welding so that a perimeter or tube/adapter leak occurs.A leak at a bonded connection due to solvent application during manufacturing.A vendor issue with the vinyl of the bag so that a hole is present.Damage to the bag related to handling during manufacturing/by the customer.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5653602
• MDR Text Key: 45986500
• Report Number: 1722028-2016-00301
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

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: 03/01/2019
• Device Catalogue Number: 70500
• Device Lot Number: 03Z15233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• 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