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

Catalog Number 12220

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/08/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time investigation: the run data file (rdf) was analyzed for this event.Review of the drdf and aim images did show signals indicating that the saline roller clamp may have been left open early in the procedure.At the beginning of the procedure, the operator did receive the ¿return saline line was not closed¿ alarm twice, but then was able to continue afterwards indicating that the return saline clamp was closed.However, twenty minutes into the run, the system generated the ¿interface took too long to establish¿ alarm¿.The ¿interface took too long to establish alarm¿ can occur for several reasons which include leaving the inlet saline roller clamp open.It is possible that the operator left the inlet saline roller clamp opened and therefore diluted what was entering the machine leading to the interface alarm.Shortly after the alarm, the operator decreased the patient hct by several points and likely closed the inlet saline clamp, as signals confirmed the interface was able to be established and the run proceeded successfully.There are alarms during the disposables test that alert the operator to possible clamping errors, loading errors, and/or disposable defects as the system is trying to achieve certain pressures in the inlet and return lines.As no alarms were generated during the disposables test, this also indicates a clamping error likely occurred after the procedure started.Per the rdf, the ending fluid balance was 122%.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that on a continuous mononuclear cell (cmnc) collection the operator forgot to close the saline line during an exchange procedure and the patient received approximately 5000ml of saline.Per the customer, there was no detection by the senor reported and no alarm.The customer reported that no serious injury occured and no medical intervention was required.Patient id and age are not available at this time.Patient gender and weight were obtained from the run data file (rdf).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 investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The procedural cautions section of the spectra optia apheresis system essentials guide, states that if the roller clamp on the saline line is left completely open when the patient is connected, the patient will be quickly infused with a large volume of saline.Investigation is in process.A follow up report will be provided.

Event Description

Pursuant to european personal data protection laws, the customer was unable to provide the patient identifier or age.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Correction: terumo bct has offered customer training for this issue.The retraining request has been accepted but has been postponed at this time due to regional restrictions related to covid-19.Retraining that was not able to be provided during covid restrictions will be monitored through quarterly review.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, e.3, h.6 and h.10.Investigation: according to the rdf, the final configured fb was 122% and the patient's tbv was 6235ml.The unintended saline bolus was calculated to be 5000ml (based on worst case scenario) which results in a worst-case fb of 202% (+102%).Adjusted final fb = (6235ml x 1.22) + 5000 ml / 6235x 100% = 202% root cause: review of the rdf and aim images did show signals indicating that the saline roller clamp may have been left open early in the procedure.At the beginning of the procedure, the operator did receive the ¿return saline line was not closed¿ alarm twice, but then was able to continue afterwards indicating that the return saline clamp was closed.However, twenty minutes into the run, the system generated the ¿interface took too long to establish¿ alarm¿.The ¿interface took too long to establish alarm¿ can occur for several reasons which include leaving the inlet saline roller clamp open.It is possible that the operator left the inlet saline roller clamp open and therefore diluted what was entering the machine leading to the interface alarm.Shortly after the alarm, the operator decreased the patient hct by several points and likely closed the inlet saline clamp, as signals confirmed the interface was able to be established and the run proceeded successfully.There are alarms during the disposables test that alert the operator to possible clamping errors, loading errors, and/or disposable defects as the system is trying to achieve certain pressures in the inlet and return lines.As no alarms were generated during the disposables test, this also indicates a clamping error likely occurred after the procedure started.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10130631
• MDR Text Key: 195443358
• Report Number: 1722028-2020-00281
• 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,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 102