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

Catalog Number 12220

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the reported event occurred to the different nurses on different machines 5 times for the same reported disposable lot number.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported a leak occurred on the disposable set during a procedure on spectra optia.Per the customer, an unknown amount of blood loss occured.It is unknown at this time if medical intervention was required for this event.The patient information and outcome is not available at this time.The optia exchange set is not available for evaluation as it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in description of event or problem and adverse event problem.Investigation is in process.A follow-up report will be provided.

Event Description

After multiple follow-up attempts, the customer did not provide patient info, outcome or additional procedural details for this event.

Manufacturer Narrative

This report is being filed to provide additional information in e.3, h.6, and h10.Investigation: a disposable history search was performed for lot 1910163230 and no similar reported occurrences have been received.Root cause:the root cause for the reported tubing set leak could not be determined.The cause of a leak at a component or assembly may be due to a hole in the component or assembly, an incomplete bond at the assembly, a welding issue, or a breakage at the tubing bond.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the device history record was reviewed for this lot.There were no issues noted that would have contrbuted to set leak experienced by the customer.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9432094
• MDR Text Key: 187443106
• Report Number: 1722028-2019-00395
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1910163230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other