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

Catalog Number 12320

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypervolemia (2664)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacture and expiry date are not available at this time.  investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell collection (cmnc) procedure on an optia device, the alarm interface was taking too long to establish, and the operator noticed that after plasma collection the inlet saline roller clamp was left open, and the clamp was in the incorrect position.The operator spiked another saline bag, closed the saline roller clamp, and continued the procedure.No blood was seen in the saline bag and there were no level sensor or fluid balance alarms.No medical intervention was reported and the patient status at the time of the event was reported as alert, oriented, stable, with no changes to baseline.Patient's age was not provided.The disposable set is not available for return because it was discarded by the customer.

Event Description

The customer reported that during a continuous mononuclear cell collection (cmnc) procedure on an optia device, the alarm interface was taking too long to establish, and the operator noticed that after plasma collection the inlet saline roller clamp was left open, and the clamp was in the incorrect position.The operator spiked another saline bag, closed the saline roller clamp, and continued the procedure.No blood was seen in the saline bag and there were no level sensor or fluid balance alarms.No medical intervention was reported and the patient status at the time of the event was reported as alert, oriented, stable, with no changes to baseline.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: the customer did not respond to multiple attempts for additional information concerning this event.A disposable lot history search indicated there were no other reported occurrence of open inlet saline roller clamp 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: 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.

• 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: 19090315
• MDR Text Key: 340581766
• Report Number: 1722028-2024-00137
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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: 12320
• Device Lot Number: 2308043241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/03/2024
• 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
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 121 KG