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

Catalog Number 4101201

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Insufficient Information (3190)

Patient Problem Hypervolemia (2664)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

The customer reported that the clamp's position was incorrect.The issue was noted when connecting the patient and the procedure was completed using hemostats.Per the customer, the final fluid balance was 123%.Full patient id - (b)(6).There was no medical intervention and the patient is in stable condition terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the clamp's position was incorrect.The issue was noted when connecting the patient and the procedure was completed using hemostats.Per the customer, the final fluid balance was 123%.Full patient id: (b)(6) there was no medical intervention and the patient is in stable condition.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: photographs were provided in lieu of the disposable set to aid in the investigation.The images show the tyvek lid of the optia collection set showing the lot number and catalog number of the implicated disposable.Additional images confirm the blue saline roller clamp is incorrectly placed on the return blood line of the disposable set and not on the return saline line as intended.The images also show the customer using a metal hemostat to stop the saline flow on the return saline line.A definitive cause could be established from the provided images, the return of the disposable set for evaluation is not necessary.A disposable complaint history search was performed for this lot and found no reports for similar issues (misassembled saline roller clamp) on this lot worldwide.Per the optia operator¿s manual, for mnc procedures, the system will only run in caution status if the target or actual fluid balance is predicted to be less than 85% or greater than 140% of the patient¿s tbv.There is no hypervolemia fluid balance limit for this procedure type.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, the cause for the blood loss into the saline bag was a manufacturing error in which the blue (return) saline roller clamp was assembled on the incorrect fluid line.

Manufacturer Narrative

Investigation: photographs were provided in lieu of the disposable set to aid in the investigation.The images show the tyvek lid of the optia collection set showing the lot number and catalog number of the implicated disposable.Additional images confirm the blue saline roller clamp is incorrectly placed on the return blood line of the disposable set and not on the return saline line as intended.The images also show the customer using a metal hemostat to stop the saline flow on the return saline line.A definitive cause could be established from the provided images, the return of the disposable set for evaluation is not necessary.A disposable complaint history search was performed for this lot and found no reports for similar issues (misassembled saline roller clamp) on this lot worldwide.Per the optia operator¿s manual, for mnc procedures, the system will only run in caution status if the target or actual fluid balance is predicted to be less than 85% or greater than 140% of the patient¿s tbv.There is no hypervolemia fluid balance limit for this procedure type.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the clamp's position was incorrect.The issue was noted when connecting the patient and the procedure was completed using hemostats.Per the customer, the final fluid balance was 123%.Full patient id (b)(6).There was no medical intervention and the patient is in stable condition.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT 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: 18283579
• MDR Text Key: 329949876
• Report Number: 1722028-2023-00407
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2023

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 Catalogue Number: 4101201
• Device Lot Number: 2302016141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 03/11/2024; 03/15/2024
• Supplement Dates FDA Received: 03/12/2024; 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2023
• 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: 12 YR
• Patient Sex: Female
• Patient Weight: 55 KG