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

Catalog Number 000000000000010220

Device Problems Air Leak (1008); Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

The customer reported that during a procedure, air was observed in the return line.There were no alarm indications by the machine.Patient outcome is unavailable at this time.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.No patient information is reasonably known.

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.Signals in the rdf showed the ¿return line air detector failed fluid check¿, which is considered to be a fail-safe alarm.This alarm occurs if the system detects air after the return line prime sub-states which is before the patient is connected.This alarm ends the procedure and forces the operator to load a new set as the existing set cannot be reused because it had already been primed and contains fluid.Root cause: although a definitive cause remains undetermined, possible causes include butare not limited to: inadequate squeezing of drip chambers to ensure they are filled with fluid.Foam or air in the return line.Defective return line air detector.Corrective/preventive action: an internal capa has been initiated to improve the reliability of the rlad during prime.

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: 4658944
• MDR Text Key: 5684466
• Report Number: 1722028-2015-00127
• 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: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• 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