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

Model Number 12320

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that the operator inadvertently left the inlet saline roller clamp open for 15 minutes during a continuous mononuclear cell (cmnc) collection procedure.The operator noticed that the roller clamp was open when the machine alarmed that the interface is taking too long to establish.She closed the clamp and started the collection.The saline bag that was hanging was 1000ml.There were 300ml left in the bag.The customer stated that the patient is stable and doing well during the collection.Patient information is not available at this time.The set is not being returned because they were able to finish the procedure.

Event Description

The customer reported that the operator inadvertently left the inlet saline roller clamp open for 15 minutes during a continuous mononuclear cell (cmnc) collection procedure.The operator noticed that the roller clamp was open when the machine alarmed that the interface is taking too long to establish.She closed the clamp and started the collection.The saline bag that was hanging was 1000ml.There were 300ml left in the bag.The customer stated that the patient is stable and doing well during the collection.Patient information is not available from the customer.Patient¿s gender and weight were obtained from the run data file (rdf).The set is not being returned because they were able to finish the procedure.

Manufacturer Narrative

This report is being filed to provide additional information in a.3, a.4, b.5, h.6 and h.10.Investigation: fluid balance reported by optia = 130% unintended saline bolus = 700ml/5114ml * 100 =14% final fluid balance including unintended saline bolus = 144% a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The run data file (rdf) was analyzed for this event.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, 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: 14187892
• MDR Text Key: 299067339
• Report Number: 1722028-2022-00134
• 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: 04/22/2022

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 Expiration Date: 11/01/2023
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2111083130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2021
• 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: Female
• Patient Weight: 96 KG