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

Catalog Number 12220

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

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

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer provided terumo bct customer support with photographs of the connector and the front of the machine, from which the tbct customer support specialist could see hemolysis in the connector and plasma line.The plasma in the plasma line was a cherry color.A disposable history search was performed for lot 1911123130.One other similar issue was reported by the same customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 3 minutes into a therapeutic plasma exchange (tpe) procedure on a pediatric patient, they received the alarm 'cells were detected in plasma line from centrifuge'.The operator stated that she performed custom prime with red cells; the patient's tbv is 952ml.This patient has history of developing clots, so she is on heparin.The operator was having issues with the access line which was very positional.The operator stated that the replacement fluid is fresh frozen plasma (ffp) and the type is compatible.The patient has had a heart transplant and she has tpe procedures twice per week; today is the first treatment of the week.The operator stated that no clots were visible in the channel or set.The patient did not receive any hemolyzed components form the channel or the reservoir.The physician asked the operator to terminate the procedure, set up the machine again, perform a custom prime, and continue.No other labs were ordered by the physician and no testing was ordered on the unit or the patient.No medical intervention was required for the patient after the terminated procedure.The operator stated that the patient did great in the second procedure.They did not send the blood prime unit for testing, but they determined the alleged hemolysis was likely related to the blood from the custom prime that was in still in the channel at the time it was observed.The patient is in stable condition.The customer declined to provide the patient identifier.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 in h.6 and h.10.Investigation: the device history record was reviewed for this lot.There were no issues noted that would have contributed to the incident experienced by the customer.The customer submitted five (5) photographs when they called for assistance with the alarm.See salesforce for attachment.The first two photographs show the connector.The interface is at 50%; however, the entire plasma layer is cherry red as described by the customer.The third photograph is a screen shot of the alarm: the system continues to detect cells in the plasma line from the centrifuge.The fourth photograph shows the cassette and illustrates the red plasma flowing from the centrifuge, through the plasma pump into the plasma line, and the replacement recirculation line, followed by the return reservoir.The picture also shows that the remove valve was occluding the plasma line so the exchange has not started yet.The patient did not receive hemolyzed custom prime blood since the hemolysis was detected, and the procedure was halted.The fifth photograph is a close-up of the four lumen channel tubing.The plasma line appears darker than normal.Root cause: based on the clinical findings, the root cause of the red plasma observed in the connector was the blood prime unit contained hemolyzed red cells.

Manufacturer Narrative

This report is being filed to provide corrected information in e.3.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9711534
• MDR Text Key: 185699340
• Report Number: 1722028-2020-00062
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2020

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: 11/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1911123130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 06/05/2020; 06/05/2020
• Supplement Dates FDA Received: 06/05/2020; 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00003 YR
• Patient Weight: 14