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

Model Number 10310

Device Problems Output Problem (3005); No Apparent Adverse Event (3189)

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

Event Date 05/22/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer called to report that the procedure was taking a long time to establish interface.The customer stated that the red roller clamp was open and there was about 200 mls left from the 1 liter bag.The customer closed the roller clamp and was able to continue the procedure.The patient received a fluid bolus of 515 ml due to clamp being open.Patient information is not available at this time.The customer was able to continue procedure; the set is not available for return for evaluation.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Fluid balance calculation that shows 116% fluid balance.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer called to report that the procedure was taking a long time to establish interface.The customer stated that the red roller clamp was open and there was about 200 mls left from the 1 liter bag.The customer closed the roller clamp and was able to continue the procedure.The patient received a fluid bolus of 515 ml due to clamp being open.Patient information is not available at this time.The customer was able to continue procedure; the 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: 14713609
• MDR Text Key: 300470092
• Report Number: 1722028-2022-00200
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• 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: 06/16/2022

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 Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/10/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other