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

Model Number 12320

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Hypervolemia (2664)

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture and expiry date not available at this time.Investigation is in process.A follow up report will be provided.

Event Description

The customer called at 29 minutes into a continuous mononuclear cell (cmnc) collection procedure and stated they had the 'interface taking too long to establish' alarm.They stated that the plasma was collected but it doesn't look like it is 100ml + 40 ml of heparin and acd-a.They were instructed by the call center confirm if the saline rollers were closed.The customer noted they had the inlet saline roller open.The customer sent a picture of the plasma, which appears to look more like saline in the collect bag.Patient total blood volume (tbv): 3362 ml, saline bag 1000ml; at time of call there were approximately 200 ml left in the saline bag.The customer started the procedure over to follow the prompts appropriately.Patient is stable and at 114% tbv.Patient information is not available at this time.The disposable set is not available for return for evaluation.

Manufacturer Narrative

Investigation: the customer provided a picture to aid in the investigation.The pictures confirmed that the contents in the collect bag contained mostly saline and anticoagulant as observed by the customer.The picture also showed a blood warmer tubing attached to the device.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.

Event Description

The customer called at 29 minutes into a continuous mononuclear cell (cmnc) collection procedure and stated they had the 'interface taking too long to establish' alarm.They stated that the plasma was collected but it doesn't look like it is 100ml + 40 ml of heparin and acd-a.They were instructed by the call center confirm if the saline rollers were closed.The customer noted they had the inlet saline roller open.The customer sent a picture of the plasma, which appears to look more like saline in the collect bag.Patient total blood volume (tbv): 3362 ml, saline bag 1000ml; at time of call there were approximately 200 ml left in the saline bag.The customer started the procedure over to follow the prompts appropriately.Patient is stable and at 114% tbv.The customer failed to respond to multiple attempts to obtain essential information like patient information.The disposable set is not available for return for evaluation.

• 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: 15565791
• MDR Text Key: 306928595
• Report Number: 1722028-2022-00329
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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