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

Catalog Number 10220

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: fluids hanging were fresh frozen plasma (ffp) and 1200ml of albumin.The run data file (rdf) was analyzed for this event.Evaluation of the rdf indicates there were no air in return line alarms and rinse back was successfully completed.The customer stated that blood warmers are not used on spectra optia aphresis machine at the customer's site since ecmo warms the blood before it returns to the patient.The customer also stated that blood prime was not performed and that the ffp was cold when entering the system.The customer provided photographs for investigation.Upon photographic inspection, tiny air bubbles were noted in the return tubing line.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient was undergoing a therapeutic plasma exchange (tpe) procedure and a concurrent treatment of extracorporeal membrane oxygenation (ecmo).During the procedure, they received an air alarm and the nurse noticed air bubbles in the return tubing line.The nurse stopped and aborted the procedure with partial rinseback.Per the customer, approximately 30 to 45ml of blood was not returned to patient.No medical intervention was required for this event and the patient is 'fine'.The customer declined to provide patient identifier (id).The tpe set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.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 confirmed that the system operated as intended.Review of the rdf indicated that at 87 minutes, the return line air detector started to detect small amounts of air in the return line.The amount of air detected in the return line never reached the alarm limits to trigger the return line air alarms.There were no air in return line alarms during this procedure and rinseback was successfully completed.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer stated that the operator noticed air bubbles in the return line past the rlad.The run data file (rdf) was analyzed to determine the alarms and signals from the return line air detector (rlad) in the optia.The rlad is situated at the exit of the return pump and is the last point of air detection in the optia circuit.There was no air alarm and all of the rinseback was successfully completed.Signals in the rdf also indicated that air was detected by the optia return line air detector (rlad) during rinseback after the procedural run was initiated, however, the cumulative air was less than the 1.0 ml needed to trigger an rlad alarm.The patient showed no symptoms or signs attributable to air embolism.Per terumo bct's internal risk documentation, outgassing of cold replacement fluids can occur when the fluids are warmed through the blood warmer in tpe procedures.When blood warmer tubing is connected to the return line, any air bubbles could be infused into the patient.Based on the calculation of the maximum rate of air generated, a low level health hazard risk from outgassing in the reported case is expected.The absence of reported clinical symptoms when outgassing has been noted and supports this contention.Root cause: during tpe procedures on spectra optia, the replacement saline, albumin or plasma may be cold.If they are not allowed to warm to room temperature, and if the return blood is warmed, air bubbles may form.The reason for this "outgassing" is that gasses are more soluble in liquids at low temperatures than at higher temperatures.If at a low storage temperature air is available to dissolve in a fluid (albumin, plasma, etc.) and approaches its equilibrium solubility at that temperature, when the fluid is warmed the air will come out of solution, because its solubility is exceeded at the higher temperature.It is usually described as chains of very small bubbles or foam, which tend to rise toward the top of the tubing.The small bubbles may coalesce to form larger bubbles.Because cold ffp was used as part of the replacement fluid in the tpe procedure, the operators used an astotherm blood warmer in the return line in each of the procedures.The astotherm blood warmer consists of a length of tubing wrapped around a heated mandrel.Heat is transferred to the return-line blood to prevent the sensation of cool return blood.The root cause for the reported air in return line was due to outgassing of small bubbles out of solution due to cold replacement fluid being warmed.The system operated as intended.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7293324
• MDR Text Key: 101149183
• Report Number: 1722028-2018-00053
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• 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,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: 10220
• Device Lot Number: 1711093230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• 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): Other
• Patient Age: 00029 YR
• Patient Weight: 47