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

Model Number 10310

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation: calculate final fluid balance (including saline bolus): 3970 ml + 683 ml + 300=4953/3970=1.25 * 100=125% investigation is in process.A follow up report will be provided.

Event Description

The customer reported that once the start run button was pushed, saline will infuse to the patient, at a fast rate despite the blue return line clamp and roller clamp being closed.They had been placing a kelly clamp on the green saline line for the remainder of the procedure, and removing it at rinse back.Once the kelly clamp is removed at rinse back the saline continues to drip quickly, so the nurse will control the flow rate by bending the saline line tubing to slow it to an acceptable rate.Patient weight and outcome are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

The customer reported that once the start run button was pushed, saline will infuse to the patient, at a fast rate despite the blue return line clamp and roller clamp being closed.They had been placing a kelly clamp on the green saline line for the remainder of the procedure, and removing it at rinse back.Once the kelly clamp is removed at rinse back the saline continues to drip quickly, so the nurse will control the flow rate by bending the saline line tubing to slow it to an acceptable rate.The customer confirmed the patient did not require medical intervention.Patient gender was not provided by the customer.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: calculate final fluid balance (including saline bolus): 3970 ml + 683 ml + 300=4953/3970=1.25 * 100=125% a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the information provided, as well as findings from the evaluation of the disposable set, the specific root cause for the reported failure could not be determined.It is possible the saline roller clamps had not been sufficiently closed, or there was an unidentified disposable manufacturing error.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 14646905
• MDR Text Key: 302067099
• Report Number: 1722028-2022-00197
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 10310
• Device Catalogue Number: 12320
• Device Lot Number: 2112023130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 64 KG