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

Catalog Number 12220

Device Problems Material Discolored (1170); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 3/4 of the way through a therapeutic plasma exchange (tpe) procedure on a patient with demyelinating disease and multiple sclerosis, they began seeing red tinged plasma going up to the remove bag and in the connector.Per the customer, the plasma was a typical yellow-tinged color at the start of the procedure and the hemolysis was not due to disease state or medication given.The operator had already disabled the rbc detector before contacting terumo bct as they had done this before on other procedures and thought this would resolve the issue.Per physician's order, the procedure was ended, and no medical intervention was necessary.The patient is reported as stable.The patient was an in-patient, so they decided to check the patient's cbc the following day, as already planned, and repeat the procedure the following monday, as already planned.The customer declined to provide the patient identifier.The exchange set was disposed of and is not available for return.

Manufacturer Narrative

This report is being filed to provide additional information in e.3, h.6, and h.10.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contriubted to the red-tinged plasma as experienced by the customer.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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9660510
• MDR Text Key: 186021146
• Report Number: 1722028-2020-00044
• 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
• Report Date: 02/03/2020

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: 01/10/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00044 YR
• Patient Weight: 79