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

Catalog Number 000000000000010220

Device Problem Air Leak (1008)

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

Event Date 12/16/2014

Event Type  malfunction  

Event Description

The customer reported that during an exchange procedure, air was observed in the return line.Patient outcome is unavailable.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Event Description

No patient was connected at the time of the event, therefore, there is no patient outcome to report.Further evaluation of this event determined that the device did not cause or contribute to a death or serious injury associated with this event based on the additional investigational information.

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 run data file (rdf) was analyzed for this event.Based on the run data file analysis, the spectra optia system operated as intended.Root cause: the disposables set was unavailable for investigation by the terumo bct disposables quality department, so no conclusion can be made about whether the air seen during the procedure was the result of a faulty disposables set.A review of the rdf for this procedure confirmed that the customer received the ¿return line air detector failed fluid check¿ during initial system prime.This alarm occurs when the return line air detector did not detect fluid when expected.The machine failed safe and there is no recovery for the alarm.The operator is directed to load a new tubing set to continue the procedure.They cannot reuse the same set because it contains fluid at the point in which this alarm occurs.Possible causes for this alarm include, but are not limited to: inadequate squeezing of drip chambers.Foam or air in the return line.Defective return line air detector.Machine issue.

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: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 4644207
• MDR Text Key: 15346451
• Report Number: 1722028-2015-00122
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 07W3115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2014
• 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