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

Catalog Number 10220

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Solutions attached: saline, acda and albumin.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a few minutes into a therapeutic plasma exchange (tpe) procedure, they began having a 'cells were detected in plasma line from centrifuge' alarm.When the customer increased the hematocrit (hct) from 41% to 43%, the alarm resolved.Per the customer, the plasma line was red until she changed the hct, then it was not red any longer.The alarm then occurred again.The customer stated that there were some red cells in the plasma line, but it was not dark red like before.The physician on call ordered to stop the procedure.The patient was in stable condition.The customer declined to provide the patient identifier and age.The disposable set is not available for return because it was discarded by the customer.

Event Description

The physician did not confirm that the hemolysis was due to disease state.No hemolysis testing was performed.It is not known if the rbcs separate when the product/tubing is spun or rested as this was not tested.The customer confirmed the attached solutions (saline, albumin and acd-a) were connected corrected.No clots were observed in the channel or channel lines.No custom prime was performed.No medical intervention was required.Multiple attempts were made to obtain the additional information, but no response was received.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, e.3, h.6 and h.10.Investigation: the customer did not provide a lot number for 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: a definitive root cause for the discolored plasma could not be determined.Possible causes include but are not limited to: a misload of the disposable set - an unidentified manufacturing defect in the disposable set - a partially open inlet line clamp - an issue with the patient's catheter (defect or misplacement) - an issue with the replacement albumin fluid - an issue with the ac solution - hematocrit entered was too low resulting in higher interface causing some rbcs to spillover into the plasma line.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11037004
• MDR Text Key: 240617086
• Report Number: 1722028-2020-00553
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91