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

Catalog Number 000000000000070500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

The customer reported that post-procedure, the rn was discarding a cobe spectra therapeutic plasma exchange (tpe) disposable set and experienced blood spray in her eyes.Follow-up diagnostic tests were performed on the rn and came back with negative results.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and 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: based on customer statements, the root cause for the operator exposure to blood occurred when the operator was disposing the set into the trash.The customer did not allege a deficiency with the disposable set resulting in blood exposure.

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 TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4742475
• MDR Text Key: 20448014
• Report Number: 1722028-2015-00164
• 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
• Report Date: 04/07/2015

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: 12/01/2017
• Device Catalogue Number: 000000000000070500
• Device Lot Number: 12W15284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 05/01/2015
• 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: 12/09/2014
• 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
• Patient Age: 00058 YR
• Patient Weight: 78