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

Catalog Number 10225

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

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

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used astotube tubing containing blood product was received for investigation.Upon visual examination of the returned component,the presence of 'pockets' of air throughout the tubing was confirmed.All connections were examined and found to be adequate and no leaks or defects on the tubing were identified.Lot number, manufacture date and expiry are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately at the end of an erythropheresis procedure onspectra optia, the nurse noticed numerous air bubbles at multiple places in the blood warmer tubing.The nurse immediately ended the procedure to avoid the possible risk of air to the patient.Per customer, all the fittings were tight and patient is reported in ¿fine¿ condition.Due to eu personal data protection laws, the patient information is not available from the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide in investigation: further evaluation of this event has determined that the device did not causeor contribute to a death or serious injury, nor is there a likely potential for death or serious injuryassociated with this event based on additional investigational information.Further follow-up withthe customer found that the set used was an amicus kit reference r6r2339 (fresenius) lotfa17h8106.The problem occurred on an amicus machine (fresenius) (serial number 4r4580)when testing for a tender.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: per the manufacturer of the astotube (stihler electronics), the outgassing offluids when heated the a known issue.Outgassing occurs differently depending on differentparameters and can never be completely avoided.The following precuations are contained withinthe ifu.- when fluids are warmed up, it is possible that gas may evolve (bubble form)- be aware of the potential for air emboli when using a blood and fluid warmer- therefore, prime all filters, lines and disposable sets before starting treatment- make sure all connections of the complete fluid stream are fixed tightly to prevent fluid leakagesand inadvertent infusion of air into the fluid stream- do not warm infusions containing soluted gas (e.G.Bicarbonate)- extreme care should always be taken to ensure that a bolus of air does not pass to the patient.The manufacturer reviewed their documentation for lot 32415108 and did not find anything thatwould have impacted what the customer experienced.There were no ncs.There were no eco(s).There were no csp's.Simulated use tests passed.Quality labs passed and sterilizationrequirements passed.In the investigation provided by stihler electronics, it was determined that the terumo bctinvestigation of the returned device indicated that the infusion extension has been in order.Stihler electronic found no abnormalities at the income inspection of batch 32415108 and thatsuch extreme outgassing may be due only to the fluid or the process.From their evaluation, thecause of the problem is therefore not the product astotube.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in root cause: the root cause of the air bubbles noted in blood warmer tubing was due tooutgassing.No other air was noted in the set and no leaks were observed during procedure.Outgassing is a known phenomenon.The replacement fluids may be cold when used.If they arenot allowed to warm to room temperature, and if the return blood is warmed, air bubbles mayform.The reason for this "outgassing" is that gasses are more soluble in liquids at lowtemperatures than at higher temperatures.If at a low storage temperature air is available todissolve in a fluid and approaches its equilibrium solubility at that temperature, when the fluid iswarmed the air will come out of solution, because its solubility is exceeded at the highertemperature.It is typically described as chains of very small bubbles or foam, which tend to risetoward the top of the tubing.The small bubbles may coalesce to form larger bubbles.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8785672
• MDR Text Key: 151004622
• Report Number: 1722028-2019-00184
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2019

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 Catalogue Number: 10225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 07/18/2019; 08/23/2019; 10/03/2019
• Supplement Dates FDA Received: 08/06/2019; 08/30/2019; 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMICUS KIT REF. (B)(4) (FRESENIUS) LOT FA17H8106; ASTOTUBE : IFT40410
• Patient Outcome(s): Other