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

Catalog Number 10220

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423)

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

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation: per the customer, the tpe procedure was performed by the renal team and an internal investigation is underway and the operator has been removed from running the procedure until the further notice.It is believed to be an operator error, as even after air was seen in the set she chose to continue and try and remove the air, and meanwhile the machine alarmed accordingly.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure on a pediatric kidney transplant patient, the operator reported seeing microbubbles in the spectraoptia set.Per the customer the disposable set was primed with saline and then re-primed with 5% albumin.Air was pulled through the entire set (at least 20ml) and out the other side.The nurse did not take down the set and start again.Instead she hung another bottle of 5% albumin and pushed the air through and out of the system.It was reported the operator received alarms during the process of pushing the air through, overrode them, and had to increase the volume of the prime in order to ensure all air had been evacuated out of the return line.Per the customer this set was then used on the patient.Throughout the run, the operator experienced air alarms and could see microbubbles in the set.Per the customer, the patient is reported to be in stable condition and was 'ok'.Exact incident date, patient identifier (id), gender and weight information are not available at this time.The tpe disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer reported that although a blood warmer was used, they do not believe that this was an issue with that.Their analysis was that when doing the blood prime, they pulled air into the inlet side of the set and then pushed the air through with another unit of blood priming solution.Correction: attempts to obtain additional information were not successful, the exact information and history pertaining to this record is unknown.This information was provided by a colleague who heard about the incident during a training session, therefore, retraining was not conducted for this event.Root cause: based on the information available, the root cause of possible air in the set during customer prime was determined to be result of a user interface error.

Manufacturer Narrative

This report is being filed to provide in investigation: the lot number was not provided, therefore, a dhr search could not beconducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process.A follow-up report will be provided.

Event Description

After multiple attempts, the customer did not provide patient id, gender, weight, exactincident date or further procedural details for this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8910907
• MDR Text Key: 165031087
• Report Number: 1722028-2019-00235
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

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: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 09/23/2019; 10/11/2019
• Supplement Dates FDA Received: 10/04/2019; 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD WARMER
• Patient Outcome(s): Other
• Patient Age: 00006 YR