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

Catalog Number 10116

Device Problems Backflow (1064); Misassembled (1398); Increase in Pressure (1491); Component Misassembled (4004)

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

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the operator found the blue clamp on the return saline line was assembled on return line.The operator decided used the set despite the issue due to there was only one set at the site.The machine alarmed return pressure high during the run, and blood was found entering into return saline line.The operator used hemostatic forceps to clamp the return saline line, then the procedure could run normally.Patient information and outcome are not available at this time.The disposable set was not returned 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.3, b.5 b.6, h.6 and h.10.Investigation : the run data file (rdf) was analyzed for this event.The system operated as intended by flagging during the pressure test with the ¿return saline line failed integrity test¿ alarm, which was generated due to the misassembled roller clamp.According to the rdf, the final configured fb was 110% and the patient's tbv was 5055ml.The unintended saline bolus was unknown (the customer declined to provide saline bag size or volume administered).A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide any further patient or procedural information.The patient gender and weight were obtained from the run data files.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: the root cause for an unintended saline bolus to the patient was due to the disposable set being manufactured without the return roller clamp on the return saline line.If this line is not clamped, saline can gravity drain freely through the return line to the patient, which can lead to a risk of hypervolemia.A definitive root cause for the roller clamp being installed on an incorrect line relates to a manufacturing mis-assembly where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.

Manufacturer Narrative

Investigation: the customer provided photographic evidence of the reported defect.The images confirmed the blue return saline roller clamp was located on the return line as opposed to the return saline line tubing.The images also indicated the presence of blood in the return line.The procedural cautions section of the spectra optia apheresis system essentials guide pg 11, 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

Per the customer, the procedure complete successfully, and the patient did not require any medical intervention.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10 additional rdf analysis: the system operated as intended by flagging during the pressure test with the ¿return saline line failed integrity test¿ alarm, which was generated due to the misassembled roller clamp.Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10472060
• MDR Text Key: 209823424
• Report Number: 1722028-2020-00417
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 10116
• Device Lot Number: 2005153230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 74