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

Catalog Number 10225

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file showed that the ¿low-level reservoir sensor detected excess fluid¿ and the ¿air was detected in return line¿ alarms were generated at 49 minutes into the procedure.The operator did correctly press the ¿air removal¿ button and proceed to perform the air removal process.During the air removal process, the system pumps approximately 20ml of saline from the saline container into the reservoir to displace the air from the return line back into the reservoir and vent bag.However, two minutes into the process, the ¿reservoir was full during air removal¿ alarm occurred, and the operator had to discontinue the procedure.This alarm can occur if there are multiple alarms occur within a short period of time or there is an air block in the plasma line so extra fluid was diverted to the reservoir causing it to fill to the high-level sensor sooner than expected and generate the safety alarm.Possible causes for the ¿air was detected in return line¿ alarm include, but are not limited to: - tubing is not correctly seated in the return pump (which can cause the return air line detector (rlad) to detect air instead of fluid in the tubing) - foam or air in the return line - defective return line air detector - machine issue investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure on a spectra optia device using albumin with 37 ° c heater, air bubbles were seen in the return line.Per the customer the procedure was ended when the air was seen.Patient identifier and outcome are unknown at this time.The exchange set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide corrected information in e.1 and e.3, and additional information in b.5, h.6 and h.10.Investigation : further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The machine alarmed correctly to alert the operator of air in the return line.The customer submitted two photographs to support the investigation.The first photograph verified a used tubing set was loaded onto the device and blood warmer tubing was connected to both the tubing set and the astotherm blood warmer.Review of this photograph confirmed air bubbles present in the return line before the astotherm blood warmer.The blood warmer tubing and return tubing luer connection was not within the field of view of the photograph.The return reservoir was noted be full and contained foam.The lower portion of the return reservoir was not within the field of view of the photograph.The second photograph supplied confirmed air bubbles in the blood warmer tubing connected to the astotherm, which is consistent with air being introduced upstream of the blood warmer tubing, hence, the receipt of the "air in the return line" alarm.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Event Description

Pursuant to eu data protection laws, further patient information could not be provided by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h1 , h6, and h10.Root cause: review of the run data file showed that the ¿low-level reservoir sensor detected excess fluid¿ and the ¿air was detected in return line¿ alarms were generated at 49 minutes into the procedure.The operator did correctly press the ¿air removal¿ button and proceed to perform the air removal process.During the air removal process, the system pumps approximately 20ml of saline from the saline container into the reservoir to displace the air from the return line back into the reservoir and vent bag.However, two minutes into the process, the ¿reservoir was full during air removal¿ alarm occurred, and the operator had to discontinue the procedure.This alarm can occur if there are multiple alarms occur within a short period of time or there is an air block in the plasma line so extra fluid was diverted to the reservoir causing it to fill to the high-level sensor sooner than expected and generate the safety alarm.Based on the analysis of the run data file and the absence of a leak, it is possible that the replacement fluid was allowed to run empty (3 alarms during 12:41-13:06) resulting in air introduced into the reservoir, and subsequently in the return line and the blood warmer tubing.Possible causes for the ¿low-level reservoir sensor detected excess fluid¿ include, but are not limited to: - albumin bottle was allowed to run empty.The negative pressure from the replacement pump created excessive foam and trigger the lower level sensor.- albumin bottle was not properly vented.As the volume of albumin decreases in a fixed container (ie, glass bottle), a vacuum effect is generated that requires venting with special tubing to equalize pressure within the bottle and atmosphere.- clotting or obstruction in the channel lines resulting in extra fluid being diverted into the return reservoir.Correction: since the nurse involved in this incident is no longer is working for the apheresis department within the hospital, the physician decided retraining was not necessary.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9682332
• MDR Text Key: 186020523
• Report Number: 1722028-2020-00054
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2020

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: 09/01/2021
• Device Catalogue Number: 10225
• Device Lot Number: 1909233230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 12/16/2020
• Supplement Dates FDA Received: 10/15/2020; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 81