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

Catalog Number 10315

Device Problems Misassembled (1398); Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that after receiving high return pressure alarms on a spectra optia device, there was saline flow from the container even with the roller clamp was in the closed position.Per the customer, it was found that the roller clamp was on the return line rather than the saline line.Due to alarms the customer discarded the disposable set and used a new set and another device to perform the procedure.Patient information and outcome are unknown at this time.The disposable set is not available for return because it was discarded by 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 additional information in a.3, a.4, b.5, b.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data shows that the return line clamp (blue clamp on return line closest to the patient) is closed until the operator is prompted by the system to open it.It was immediately after this prompt was cleared that multiple ¿return pressure was too high¿ alarms were generated.Based on the high return pressures seen by the system, it is likely that after the blue return clamp was opened when prompted, however the mis-assembled roller clamp on the return line was still closed.Therefore, the maximum amount of time that un-intended saline that could have been returned to the patient was over the 5-minute time period which the return line clamp was opened.Investigation is in process, a follow-up report will be provided.

Event Description

Patient gender and weight obtained from run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information in e.1, e.3, h.6, and h.10.Root cause: the disposable set was manufactured without the return roller clamp on the return saline line.When this line was not clamped, saline gravity drained freely through the return line to the patient.The cause of the defect was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: per the run data file, the final configured fluid balance was 138% / patient tbv: 4886mls.Unintended saline volume was calculated to be 700ml (based on rdf and use of 1l saline bag), which results in a worst-case unintended fluid balance of +14%.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the hypervolemia as experienced by the customer.The customer submitted photographs to aid in the investigation.The submitted photographs confirm the mis-assembly of the blue saline roller clamp on the return line instead of the return saline line.Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue on 02/04/2020 and retrained to the appropriate procedures on (b)(6) 2020.Investigation is in process.A follow up report will be provided.

Event Description

During follow-up with the customer, it was reported that the procedure was started but they needed to clamp the saline line to continue the process.Therefore, they do not know exactly how much saline was delivered to the patient, but they do know it was a little more than normal.A 1 liter bag of saline was used for this procedure.The customer declined to provide the patient identifier and age.No medical intervention was necessary for this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9490187
• MDR Text Key: 187101382
• Report Number: 1722028-2019-00422
• Device Sequence Number: 1
• Product Code: GKT
• 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,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 10315
• Device Lot Number: 1904033130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 78