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

Catalog Number 12120

Device Problems Use of Device Problem (1670); No Flow (2991); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Reaction (2414); No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Investigation: per the customer, acda is routinely added to the product collected from a patient in order to prevent the product clotting.It was reported that the apheresis rn had taken the recording of the amount of acd added to the product from the apheresis machine during the procedure and is in accordance with their internal policy indicating that the acda was being added to the collection correctly.Gcsf was part of the initial regime, as part of the first (unsuccessful)collection.Day 2 of gcsf was always a potential for the patient pending day 1 collection result so not necessarily extra treatment.In aug 2017,terumo bct introduced a new apheresis anticoagulant connecter as a safety measure to prevent misconnections of the anticoagulant with other apheresis solutions.The connector also called as correct connect connector requires a frangible to be manually broken to enable the acda to flow into the machine.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

The customer reported that a patient was undergoing a stem cell harvest apheresis procedure on spectra optia.Per the customer, the patient experienced some mild side effects in response to the granulocyte colony stimulating factor (gcsf) therapy.The customer stated that after the patient was connected to the apheresis machine, the first bag of 500 ml of anticoagulant citrate dextrose solution, solution a (acda) was put up correctly and the frangible was broken without any issue.Once the acda bag was finished, a second bag of acda was attached and the attending nurse broke the frangible.However, it was noticed that the acda did not flow into the machine and found that the frangible was not broken.The customer stated that the attending nurse have been using the newly introduced connector for a while and informed that it is difficult to visually detect with the new connector if the frangible has been broken.Per the customer, the machine did not detect that there was no flow of anticoagulant, instead recorded it as the acda was flowing.During the procedure, the lead rn noticed that the collection had not been anticoagulated properly and became clotted in the bag.The second bag of acda appeared to be full have 500mls of anticoagulant however the apheresis machine had recorded that 1019 mls of acda had been added to the product.The customer stated that procedure was stopped and product was destroyed in the laboratory resulting in no stem cell collection on that set day.On following day, per physician's order with the usage of unplanned gcsf therapy the same donor undergone a second apheresis procedure successfully and the collected product was sent to the transplant centre.The customer reported no 'ill effects' on the donor from the procedure.Per the customer there was no medical intervention given to the patient following the incident, beyond the extra day of gcsf.This was unplanned, but required to improve the likelihood of a successful second collection.The disposable collection set is not available for return because it was discarded by the customer.Due to eu personal data protection laws, the patient information is not available from the customer.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.Donor gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information in sex, weight, event, relevant tests/laboratory data.Investigation: the run data file (rdf) was analyzed for this event.The signals in the rd indicate that the spectra optia system operated as intended.Review of the rdf and associated images for this procedure confirmed the presence of clumping in the connector.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.The clumping persisted and worsened with numerous inlet/return pressure alarms and ¿red blood cells were detected too soon¿ alarms.The ¿pressure in collect line was too high¿ alarm was generated, and the run was ended by the operator.Between the time of the bag change and the end of the procedure there were: nine inlet/return pressure alarms, three ¿rbcs detected too soon¿ alarms and one ¿collect line pressure¿ alarm generated.Given the timing of these alarms and the development of the clumping in the connector after the ac bag was changed confirmed by the aim images, 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.This can allow fluid to be consistently present at the ac detector, while limiting flow through the ac line at the same time.The operator indicated the frangible may not have been broken fully when the second bag of ac was hung.The spectra optia system is designed to monitor fluid presence in the ac line using the ac fluid detector throughout the procedure.The signals in the run data file 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 them anifold 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.If the operator suspects ac is not flowing to the system at any time throughout the procedure, they should verify the frangible on the correct connect system on the ac line is completely broken, there are no obstructions in the line, and fluid is continually dripping into the drip chamber.Correction: terumo bct followed up with the customer and retraining on breaking the frangible was conducted at the customer site by the tbct sales specialist on (b)(6) 2019.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: as a result of the clotting observed, an extra day of cgsf was required formedical intervention.Review of the rdf and associated images for this procedure confirmed thepresence of clumping in the connector starting approximately 106 minutes into the procedure(as calculated from the time the ¿start¿ button was pressed).This timing correlates with afterthe ac bag was suspected to have been changed based on the occurrence of the ¿accontainer is almost empty¿ alert at 86 minutes elapsed run time and the system prediction of500ml of ac consumed at 95 minutes (note: the device was configured for 500ml bagvolumes).The clumping persisted and worsened at approximately 128 minutes elapsed runtime with numerous inlet/return pressure alarms and ¿red blood cells were detected too soon¿alarms.At 194 minutes, the ¿pressure in collect line was too high¿ alarm was generated, andthe run was ended by the operator.Between the time of the bag change and the end of theprocedure there were: nine inlet/return pressure alarms, three ¿rbcs detected too soon¿ alarmsand one ¿collect line pressure¿ alarm generated.Given the timing of these alarms and thedevelopment of the clumping in the connector after the ac bag was changed confirmed bythe aim images, an occlusion in the ac line after the bag change is suspected.Possible causesfor this include:- the ac line becoming partially occluded as a result of loading into the ac fluid detector or bysome component near the ac line such as a blood warmer- 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 limitingflow through the ac line at the same time.In this particular instance, the operator indicatedthe frangible may not have been broken fully when they hung the second bag of ac.Thespectra optia system is designed to monitor fluid presence in the ac line using the ac fluiddetector throughout the procedure.The signals in the run data file indicate that the ac fluiddetector was functioning as intended, as the sensor saw fluid in the ac line during ac prime, atthe beginning of the procedure, and throughout the run.Furthermore, during ac prime, thesystem uses the inlet pressure sensor to verify that the ac line is not initially occluded.Oncethe procedure is started and patient blood and ac are brought into the manifold via the inletand ac pumps, there is no way for the optia system to differentiate between the types offluid being brought into the cassette.Consequently, the inlet pressure sensor is no longer ableto check ac fluid presence during the procedure.There were no alarms during ac prime tosuggest an occlusion was present in the ac line at the start of the procedure.However, if theoperator suspects ac is not flowing to the system at any time throughout the procedure,they should verify the frangible on the correct connect system on the ac line is completelybroken, there are no obstructions in the line, and fluid is continually dripping into the dripchamber.In general, the likelihood for platelet clumping to occur during a run is difficult topredict since it is not dependent on a specific platelet count and varies by patient.Therefore,every procedure should be observed for clumping in the connector, particularly at the interfacebefore the collect port and the collect port.

Manufacturer Narrative

Investigation:this report is being filed to provide additional information per terumo bct medical review, the device (via the malunction of operator error) contributed tothe outcome of the reported event.Investigation is in-process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8382004
• MDR Text Key: 137538749
• Report Number: 1722028-2019-00041
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: 12120
• Device Lot Number: 1807163330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 03/19/2019; 04/16/2019; 05/09/2019
• Supplement Dates FDA Received: 03/26/2019; 04/19/2019; 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 108