MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: this issue was identified during an internal evaluation of available run data files.As part of the internal analysis, run data files are filtered to exclude known test machines housed at terumo bct in (b)(6) as well as run data files that meet criteria indicating the run was performed with saline as part of a preventive maintenance procedure.The device this incident occurred on, s/n (b)(4), was updated to v11.3 on (b)(6), 2016 which no longer allow for height and weight data entry errors.One year of service history was reviewed for this device with no issues related to the reported condition identified.Investigation is in process.A follow-up report will be provided.

Event Description

An internal review of available run data files was performed.This run was identified as having patient data entered that led to an unreasonable patient body mass index.Patient height was entered as 70cm and weight was entered as 95kg.Calculated bmi is 193.9.Patient information and outcome are not available at this time.

Manufacturer Narrative

This report is being filed to report additional information in h.7 and h.10.Corrective action: an internal capa was conducted for the entry of transposed patient height and weight.Per optia field action 24, all optia devices in the field have been updated to software version 11.3.This software version will allow the optia device to determine if entered patient height and weight combinations are feasible.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in e.1, e.3.And h.10.Investigation: the customer provided the following patient data which indicates there were multiple data entry errors.- gender: male - height: 175cm - weight: 95kg - bmi: 31 - procedure: tpe - date: 20/07/2020 - time: 14.36 initially, the user made an error in entering the patient's height, 70 cm, instead of 175 cm, which was never corrected.Then the operator manually entered the patient's tbv as 4001 ml at 15:34 minutes into the procedure.Using the values the customer provided, the actual tbv for this patient was 5629 ml (calculated with the nadler tbv formula).Based on this information, there was no risk of ac over infusion to the patient.One of the software requirements related to the bmi check and tbv warning is to offer a bmi warning screen that will prompt the operator to check height/weight values and units for errors, but will allow them to proceed past the bmi warning screen if they enter 2 tbv values that match, which is what occurred in this case.The run data file (rdf) was analyzed for this event.Review of the rdf showed the software alerted the customer of the possible entry error; however, the customer chose to manually enter the tbv and continue with procedure.Root cause : the root cause of the failure was user interface issue.Corrected correction: optia field action 24 addressed this issue by releasing a safety notification to all optia users to express the importance of entering the correct patient data and following the operator's manual and on-screen prompts.

Event Description

The customer declined to provide the patient's id and age.The customer confirmed there was no patient injury or medical intervention required.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11302310
• MDR Text Key: 252360390
• Report Number: 1722028-2021-00061
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 95