MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET

Catalog Number 10310

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Per the rdf, the spectra optia system operated as intended and based on the information provided by the customer, it was reported that the saline roller clamp on the inlet line was left partially open which would explain why there was no interface in the channel and no cells in the collect port for the first 30 minutes of the procedure.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported that about 25 minutes into a mononuclear collection (mnc) procedure,she noticed the interface was low and she wasn't seeing any cells in the collect port.She then realized that she had left the saline roller clamp open.She stated that the patient had received about 500 mls of saline.She closed the saline roller clamp and was able to complete the procedure successfully.Per the staff nurse there was no medical intervention required and no patient follow-up was needed.The patient was in heathy condition following the procedure.The customer declined to provide the patient's identifier.The disposable set will not be returned for evaluation since the procedure was completed successfully on the same set after the roller clamp was closed.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the roller clamp being left open by the operator as experienced with this event.Root cause: the spectra optia system operated as intended per the run data file (rdf), and based on the information provided by the customer, it was reported that the saline roller clamp on the inlet line was left partially open.Based on customer statement and the rdf analysis, the root cause is determined to be that the operator left the saline roller clamp open.Correction: training was offered to the customer by terumo bct, but the customer declined because they had addressed the issue internally.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5717744
• MDR Text Key: 48210391
• Report Number: 1722028-2016-00364
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140191
• 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: 06/10/2016

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: 03/01/2018
• Device Catalogue Number: 10310
• Device Lot Number: 03Z3324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/10/2016
• 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: 03/24/2016
• 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: 00074 YR
• Patient Weight: 43