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

Catalog Number 12320

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypervolemia (2664)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

The customer reported that during a procedure the nurse left the inlet saline roller clamp open on a spectra optia device and 500 ml of saline was transfused into the donor.The nurse spiked a new saline bag and was able to complete the procedure.Per the customer, the nurse was not concerned about the saline bolus that the donor received because the donor was "not a small person".Patient information and outcome are unknown.The customer failed to respond to multiple attempts to obtain essential information.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer did not respond to multiple requests for lot number.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Correction: retraining was not completed since the customer failed to respond to multiple attempts to contact them.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime divert.

• 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: 18905320
• MDR Text Key: 337745336
• Report Number: 1722028-2024-00082
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2013
• 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