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

Catalog Number 12120

Device Problems Clumping in Device or Device Ingredient (1095); Use of Device Problem (1670); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012)

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

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, they performed a collection on (b)(6) 2018 and then twice on (b)(6) 2018 with no further collections performed for this patient.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 during a stem cell collection procedure, the operator noticed clumping at the connector shortly before the procedure was unexpectedly terminated at approximately 172 minutes.The ac ratio was adjusted from 13.5:1 to 8:1 and the chamber volume was collected.The system then returned to re-establishing interface, a return pressure alarm occured and the centrifuge stopped.They were unable to resolve the alarm and they noticed that the patient's femoral lines was clotted.Rinseback was not performed.Per the laboratory at the customer site, the product was clotted and therefore they were unable to process and use as part of the transplant.The customer set up another spectra optia machine the same day and was able to collected for another 155 mins using an ac ratio of 8:1.It was reported that they saw some further clotting, therefore, the patient was given a heparin bolus of 2500 iu and the procedure was finished with no further issues.Due to eu personal data protection laws, the patient information and outcome are not available from the customer.The stem cell collection 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: the run data file was analyzed for this event.Review of the dlog and images for the procedure, did show signs of clumping in the connector starting at 48 minutes into the run and continuing to worsen throughout the procedure.The inlet:ac ratio was set at 13.5 for this procedure and was not changed until 154 minutes into the run when it was decreased to 10.At 158 minutes into the run, the ¿decrease inlet:ac ratio¿ button was pressed which decreased the inlet:ac ratio to 8:1 while the system processed 100ml of inlet volume.Six minutes later, there were two ¿return pressure was too high¿ alarms and the procedure was ended by the operator.Rinseback was not performed.Root cause: root cause remains undetermined at this time.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.The default inlet:ac ratio for mnc procedures is 12.This value maybe increased to accommodate the needs of the procedure; however, those needs should be balanced with the increased risk of platelet clumping and separation issues as increasing the ratio decreases how well the extracorporeal circuit is anticoagulated.Therefore, every procedure should be observed for clumping in the connector, particularly at the interface before the collect port and the collect port.If a clump is observed in these locations, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8 immediately before it continues to worsen as it is more difficult to address.

Event Description

Patient gender and weight were obtained from the run data files (rdf).

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7802375
• MDR Text Key: 118253824
• Report Number: 1722028-2018-00223
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 12120
• Device Lot Number: 1712153330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2017
• 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: 112