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); Tachycardia (2095)

Event Date 03/11/2020

Event Type  Injury  

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, there were air bubbles seen past the point of detection by the machine.In the blood warmer tubing line, microbubbles that formed into a big bubble were noted and the procedure was stopped.The patient remained alert and awake; no hypoxemia.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.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: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.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.The operator noted that no hypoxemia was observed in the patient, asserting an air embolism did not occur.Given the patient's type of symptoms, she was likely experiencing typical reactions related to collection procedures and/or her medical condition.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable history search for lot 1912093230 found no other reports of a similar failure.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Analysis of the run data file was not performed; however, the operator confirmed there were no rlad alarms during the procedure which indicate the air bubbles were isolated to the blood warmer tubing and were likely a result of outgassing.This phenomenon, called "outgassing," occurs because gasses are more soluble in low temperature liquids than in liquids at higher temperatures.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.If replacement fluids are not allowed to warm to room temperature prior to procedures, 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.Outgassing is sometimes also seen when blood or replacement fluids are re-warmed by the blood warmer in procedures.Correction: 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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10121134
• MDR Text Key: 196112807
• Report Number: 1722028-2020-00272
• Device Sequence Number: 1
• Product Code: LKN
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 1912093230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD WARMER - ASTOTHERM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 18 MO
• Patient Weight: 10