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

Catalog Number 000000000000010220

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 04/15/2014

Event Type  Injury  

Event Description

The customer reported that when there were 7 minutes left in a therapeutic plasma exchange(tpe) procedure, they received a return line air detector (rlad) alarm.The operator reported seeing a small air bubble in the return pump.The operator followed the machine prompts toback-prime, then received the rlad alarm again.The operator back-primed again, but then the reservoir was full and the operator had to end the procedure without rinseback for the patient.The operator was able to rinse the access and return line red blood cells back to the patient.The patient was seen by the physician who ordered a bolus of 200ml 5% albumin be administered to the patient.The patient was then discharged home.The customer declined to provide the patient identifier, age and weight.The disposable set is not available for return because it was discarded by the customer.This report is being filed due to medical intervention in the form of the albumin bolus.

Manufacturer Narrative

Investigation: the disposable set was not available for return and analysis.A machine service call was placed and the machine was determined to be working as designed.A mono-nuclear cell collection saline run was completed successfully.The nurse at the customer site performed a tpe saline run with the terumo bct service technician, which was also completed successfully.The run data files were analyzed for this event.It was confirmed that the customer experienced an "air was detected in the return line" alarm at 34 minutes into the procedure.The past alarm history of the machine showed that the rlad was working as designed by detecting air when it was present on previous runs.Root cause: a definitive root cause could not be determined.The alarm, "air detected in the return line" is likely, but not limited to, foaming or air in the return line, or decoupling of the tubing from the sensor.The alarm, "return line air detector failed fluid check", as seen in the machine's past alarm history, is likely, but not limited to, drip chambers not being sufficiently filled by the operator, or the operator not opening and closing the roller clamps when prompted.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury on the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: kristen cohen ; 10811 w collins avenue; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 3808683
• MDR Text Key: 15109950
• Report Number: 1722028-2014-00170
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK870022
• 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
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000000000000010220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 50