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

Catalog Number 000000000000070629

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/09/2015

Event Type  malfunction  

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.The machine was checked out at the customer site by a (b)(4) bct service technician.The machine was tested and calibrations and sensors were verified to be within manufacturer specifications.Root cause: per customer statements, the blood exposure was related to a leak of the disposable set.A definitive root cause for the leak could not be determined because the part was not available for evaluation.Possible causes for a leak include a hole in the component or assembly, an incomplete bond at the assembly, a welding issue, or a breakage at the tubing bond.It is also inconclusive how the leak resulted in blood exposure on the facial area but it is possible that the operators were exposed by how they handled the leaking disposable set when transferring the plasma into the collection bag.

Event Description

The customer reported that during rinseback of a mononuclear cell (mnc) collection procedure,the rn experienced blood spray to her face.She noticed a leak in the tubing and in front of the machine below the plasma and collection bag.The rn washed her face and a postexposure laboratory testing was given and awaiting on test results.The rn is reported in healthy condition.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Event Description

Post-exposure laboratory tests were received with (b)(6) test results.

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 SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA CLOSED WHITE BLOOD CELL COLLECT 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: 4887207
• MDR Text Key: 22515905
• Report Number: 1722028-2015-00240
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2015

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: 02/01/2017
• Device Catalogue Number: 000000000000070629
• Device Lot Number: 02Y15286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• 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
• Patient Age: 00030 YR
• Patient Weight: 59