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

Catalog Number 12320

Device Problems Air Leak (1008); Coagulation in Device or Device Ingredient (1096); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, there was no alarm during the 2 hour period between the connection of the second acda bag and when the operator noticed there was not acda flow.The customer stated that the ac frangible was not broken on the second acda bag.The run data file (rdf) was analyzed for this event.Review of the rdf and associated interface aim images for this procedure confirmed the presence of clumping in the connector starting approximately 187 minutes into the procedure (as calculated from the time the ¿start¿ button was pressed).This timing correlates with after the ac bag was suspected to have been changed based on the occurrence of the ¿ac container is almost empty¿ alert at 138 minutes elapsed run time and the system prediction of 750ml of ac consumed at 153 minutes.The clumping persisted at a low-level and worsened at approximately 222 minutes elapsed run time.The procedure was eventually ended by the operator at 294 minutes.Between the time of the bag change and the end of the procedure, eight return pressure alarms, two interface alarms, and one rlad alarm were generated.Given the timing of these alarms and the development of the clumping in the connector after the ac bag was changed, an occlusion in the ac line after the bag change is suspected.Possible causes for this include the ac line becoming partially occluded as a result of loading into the ac fluid detector or by some component near the ac line such as a blood warmer, or an incomplete break of the frangible on the correct connect system.In either case, this can allow fluid to be consistently present at the ac detector, while limiting flow through the ac line at the same time.In this particular instance, the operator indicated the frangible was not broken when they hung the second bag of ac.The signals in the rdf indicate that the ac fluid detector was functioning as intended, as the sensor saw fluid in the ac line during ac prime, at the beginning of the procedure, and throughout the run.Furthermore, during ac prime, the system uses the inlet pressure sensor to verify that the ac line is not initially occluded.Once the procedure is started and patient blood and ac are brought into the manifold via the inlet and ac pumps, there is no way for the optia system to differentiate between the types of fluid being brought into the cassette.Consequently, the inlet pressure sensor is no longer able to check ac fluid presence during the procedure.There were no alarms during ac prime to suggest an occlusion was present in the ac line at the start of the procedure.It is also noted that the operator did appropriately attempt to decrease the inlet:ac ratio once the clumping was identified.However, this action was not taken until approximately 100 minutes after clumping was first noticeable in the connector.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continous mononuclear cell (cmnc) collection procedure, they observed clotting in the cmnc set.Approximately 2 hours after the operator hung the second anti-coagulant (acda) solution bag, they received a 'air in the return line' alarm.While the operator was troubleshooting, it was discovered that the return line and the disposable set was clotted.Per the customer, no medical intervention was required for this event.Due to eu personal data protection laws, the patient information is not available from the customer.Patient's gender and weight were obtained from the run data file (rdf).The cmnc 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.Root cause: based on customer statement that they noticed the frangible for the second acda bag was not broken and the rdf analysis that supports this based on timing of alarms, the root cause for the clotting was the frangible of the second bag not being fully broken to allow acda to flow.The system operated as intended.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6682489
• MDR Text Key: 79146692
• Report Number: 1722028-2017-00272
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: 12320
• Device Lot Number: 01A3316
• Other Device ID Number: 05020583123205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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 Weight: 80