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

Model Number 12320

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); No Known Impact Or Consequence To Patient (2692); Test Result (2695)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer performed a custom prime for this procedure and the leurs were tight.The customer also reported that the patients mother was concerned the patient received air, but it has not been confirmed if that did occur.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection using a spectra optia device, there were air bubbles seen in the tubing towards the return access.In the blood warmer tubing line, microbubbles that formed into a big bubble was noted and the procedure was stopped.The patient remained alert and awake; no hypoxemia was reported.An ecg was ordered.A cbc was drawn, which showed severe anemia and worsening thrombocytopenia.The patient received packed red blood cells because the hemoglobin dropped from 8 to 5.5.Saline was provided to the patient because the patient had gotten tachycardic and hypotensive.Per the customer no medical intervention was required and the air was aspirated with a syringe after pausing the procedure.The patient was admitted for monitoring and for a 2nd collection and is continuing oncology road map or treatment plan.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: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.During therapeutic procedures on the spectra optia systems, the replacement fluid may be cold.If it is not allowed to warm to room temperature, and if the blood returned to the patient is warmed using a blood warmer, air bubbles may form during warming.They are usually described as chains of very small bubbles or foam, which tend to rise toward the top of the tubing and may coalesce to form larger bubbles.This phenomenon, called "outgassing," occurs because gasses are more soluble in low temperature liquids than in liquids at higher te mperatures.If air is available to dissolve in a fluid at a low storage temperature and approaches its equilibrium solubility at that temperature, the air will come out of the solution when the fluid is warmed because its solubility is exceeded at the higher temperature.Outgassing is sometimes also seen when blood or replacement fluids are re-warmed by the blood warmer in procedures.Correction: the terumo bct clinical specialist provided the operator with outgassing information and the blood warmer ifu for tubing connections.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Root cause: based on information provided in the clinical findings, the root cause of the air bubbles noted in blood warmer tubing are a result of outgassing.

Event Description

Per the customer, the patient was stable at the end of the procedure and no medical intervention was required.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10123715
• MDR Text Key: 200864993
• Report Number: 1722028-2020-00276
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• 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: 06/05/2020

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: 07/01/2021
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 1907123130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 09/29/2020
• Supplement Dates FDA Received: 09/25/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASTOTHERM.
• Patient Outcome(s): Other
• Patient Age: 18 MO
• Patient Weight: 10