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

Catalog Number 12120

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that 836 ml of anti-coagulant (ac) was used.The customer stated that they have experienced hyper viscosity in the past with all patient groups including donors and myeloma patients.The stem cells were not stored overnight, they started to clot at the lab shortly after arrival.The customer did not return the mnc disposable set for investigation, however, photographs were provided.Upon photographic inspection, it was noted that final stem cell product was completely clotted.During customer follow up, the customer stated that they checked the patient's fibrinogen and test results indicated they were normal post procedure.The customer also stated that they performed a lipid screen to rule out lipaemia in (b)(6) 2017 since they did not encounter platelet clumping on the previous day which would perhaps justify clots in the stemcell product.Test results of the patient's lipid screen was in fact deranged with triglycerides and cholesterol ldh ratio very high.A service call was completed and it was confirmed that the machine operated as intended and there was no malfunction.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.Root cause: signals in the rdf analysis and associated aim interface images for this procedure confirmed the presence of clumping in the connector starting approximately 25 minutes into the procedure.The clumping persisted and worsened approximately throughout the procedure, likely leading to a block of the collect line and causing the ¿volume in collection bag may be lower than reported¿ alarm later on in the procedure.The clumping continued to worsen and ultimately resulted in several ¿return pressure was too high¿ alarms towards the end of the procedure and during rinseback.These signals suggest that the clumping and clotting experienced during this procedure were likely related to the patient¿s individual blood physiology and inadequate anticoagulation of the extracorporeal circuit.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 inlet:ac ratio was set to 13.5 at the beginning of the procedure and not decreased throughout the entirety of the procedure.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 indicated 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.There were no alarms during ac prime to suggest an occlusion was present in the ac line at the start of the procedure.

Event Description

The customer initially reported that towards the end of a mononuclear cell collection (mnc)procedure, they observed clotting in the patient's return tubing line.The operator ended the procedure without rinseback and disconnected the patient.Per customer, there were no visible clots in the mnc disposable set and they received no alarms during the procedure.Post procedure, the patient¿s stem cell product was sent to a stem cell lab and the lab technician observed clotting in the patient's stem cell product on arrival.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 mnc collection set is not available for return because it was discarded by the customer.

• 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: 7049669
• MDR Text Key: 93441438
• Report Number: 1722028-2017-00451
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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
• Report Date: 11/21/2017

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: 05/01/2019
• Device Catalogue Number: 12120
• Device Lot Number: 05A3223
• Other Device ID Number: 05020583121201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• 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: 72