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

Catalog Number 10220

Device Problems Coagulation in Device or Device Ingredient (1096); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

Device lot #, manufacture date, and expiry are not available at this time.Investigation: during customer follow-up, the physician stated that 800mg of calcium chloride (cacl2) per 100ml of saline is infused at 75ml/h and after reviewing the patient's chart, it was determined that the patient's calcium usage may have contributed to the clotting that they observed during the procedure.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that near the end of red blood cell depletion/exchange (rbcdx)procedure, they have seen clotting in the tubing set.The customer stated that the clotting was observed 'in the circuits' late into the procedure.During this procedure, they had increased the hematocrit 5% points from the starting procedure.They did not adjust the anti-coagulant ratio when clots were observed, instead, they flushed the access line.Patient information and outcome are not available at this time.The disposable 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: during customer follow-up, the customer stated that she was only aware of one patient in particular that clotting occurred during a procedure.She reviewed the patient's chart and noted that the patient underwent the procedures on (b)(6) 2016.However, she was unsure of the procedural dates when the clotting issues occurred.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Interface images determined that there were no indications of clumping in the channel.The customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause:the root cause for this particular issue is unknown at this time.Possible causes include but are not limited to:- patient physiology- patient access problem- ac ratio issues- need for the addition of saline during the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6149418
• MDR Text Key: 62127257
• Report Number: 1722028-2016-00633
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• 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
• Report Date: 12/06/2016

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 Catalogue Number: 10220
• Other Device ID Number: 05020583102200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2017; 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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