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

Catalog Number 10310

Device Problem Clumping in Device or Device Ingredient (1095)

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

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, no clotting was noted during the procedure anywhere in the set.When the operator started rinse back, he began to see clumping in the collection bag and agitated the bag.He did not see any clumping in the collect line going to the collection bag.He finished rinse back to the patient without any problems.The collected product appeared to be clotted to him and another colleague when he was preparing the bag for transport to the lab.Per the customer, 12.2mls of acda was added to the collection bag prior to the start of the procedure.The customer stated that they set the anticoagulant (ac) ratio of 12:1 for a platelet count of 292.Per the customer, the clotting could have not been returned to the patient because the collect valve was closed to the collection bag and the operator did not see any clots in the collect line leading to the collection bag.Complete blood count (cbc) testing was performed and product cultures taken with negative test results.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that following a continuous mononuclear cell (cmnc) collection procedure, clotting was noted in the collection bag.Rinse back was completed successfully at the end of the procedure and there were no patient problems.No viable product was collected.This was an allogeneic donor.The recipient patient had already been prepared for transplant, so the donor had to come back in for a bone marrow aspiration and was hospitalized.The patient (donor) is reported in healthy condition.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf indicated that the spectra optia system operated as intended.The interface images indicated that there was some minor clumping present in the collect port throughout the collection, but the inlet/ac ratio remained at 12 for the entire collection.The signals in the run data file (rdf) also confirmed that the ac fluid detector was functioning as intended and appropriately identifying fluid and air throughout the procedure.The disposable set was returned for investigation.Upon visual inspection, there was no indication of any occlusions of the ac line that could have resulted in any under delivery of ac to the circuit.Investigation is in progress.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the machine involved in this event was evaluated.An autotest and simulated patient run were conducted.The technician was unable to duplicate the reported condition.Investigation is in progress.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the product clotting as experienced by the customer.Root cause: the signals in the run data file and the investigation of the returned disposable set do not indicate a clear root cause for the clotting observed in the product bag at the end of the procedure.Based on the information available the spectra optia system operated as intended.Possible causes for the clotting include but are not limited to donor physiology and/or inadequate ac ratio for the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5582342
• MDR Text Key: 42853326
• Report Number: 1722028-2016-00250
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK151368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2016

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: 01/01/2018
• Device Catalogue Number: 10310
• Device Lot Number: 01Z3227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/10/2016; 06/03/2016; 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• 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): Hospitalization; Other
• Patient Age: 28 YR
• Patient Weight: 152