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

Catalog Number 12320

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

The customer reported to terumo bct customer support that they were having issues establishing the interface during a continuous mononuclear cell collection (cmnc) procedure.Customer support asked the operator to check the saline rollers and she stated that that the inlet roller was open, so she closed it and spiked another bag and continued.The dr.Was notified and he did not have concerns of any fluid overload.There was no medical intervention and the patient is in stable condition.After multiple follow-up attempts, no further details were provided for this event.Therefore, patient id and age are not available.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable lot history search indicated there were no other reported occurrences of open inlet saline roller clamp on this lot worldwide.Correction: terumo bct clinical specialist reminded the customer to check and make sure that the saline roller clamps were closed.The customer verified and acknowledged that the inlet saline roller clamp was inadvertently left open.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that they were having issues establishing the interface during a continuous mononuclear cell collection (cmnc) procedure.Customer support asked the operator to check the saline rollers and she stated that that the inlet roller was open, so she closed it and spiked another bag and continued.The dr.Was notified and he did not have concerns of any fluid overload.There was no medical intervention and the patient is in stable condition.After multiple follow-up attempts, no further details were provided for this event.Therefore, patient id and age are not available.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide investigation: a disposable lot history search indicated there were no other reported occurrences 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.Correction: terumo bct clinical specialist reminded the customer to check and make sure that the saline roller clamps were closed.The customer verified and acknowledged that the inlet saline roller clamp was inadvertently left open.Root cause: a root cause assessment was performed for the unintended saline bolus to the donor.Based on the customer's statements, she failed to follow the screen prompt to fully close the inlet saline roller clamp at the end of 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: 18012109
• MDR Text Key: 326622777
• Report Number: 1722028-2023-00351
• Device Sequence Number: 1
• Product Code: LKN
• 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,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• 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: 2208083230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2022
• 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 Sex: Male
• Patient Weight: 76 KG