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

Catalog Number 10120

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

Per the rn, during the procedure, the procedure was paused for the patient to use the restroom.The collection set was returned to terumo bct for evaluation with the plasma bag still attached and unsed.The disposable was visually inspected for any misassembly, obstruction, or other defect that could have contributed to the reported procedural issues.No anomalies were observed in the inspection.It was noted that the inlet saline roller clamp was returned in the open position.The blood within the inlet manifold was observed to be heavily diluted as opposed to the rich color visible in the return manifold.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a mononuclear cell (mnc) collection procedure, they noticed the saline was running.The rn stated that the roller clamps were on the correct tubing lines and the saline roller clamps were closed on the access and return lines.The procedure was able to run to completion successfully.Per the rn, the patient received approximately 300 mls of saline.The patient left the customer's site with no complaints and is reported in healthy condition.

Manufacturer Narrative

This report is being filed to provide additional information.Additional 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.A calculation was performed for the potential hypervolemia for this event.Calculations determined that the total amount of saline returned to the patient was 300ml which was 5% of the total blood volume.

Manufacturer Narrative

This report is being filed to provide additional information.(b)(4).Investigation: during customer follow-up, the customer stated that the patient did not require treatment 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.A service call was placed and a full machine checkout was performed.The service technician also verified all valves and pressure sensors.The machine is functioning manufacturer's specification.An autotest and saline run were successfully completed.Root cause: a definitive root cause was not determined.It is possible that the saline clamp did not fully occlude the tubing line during the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6556103
• MDR Text Key: 74910028
• Report Number: 1722028-2017-00177
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 10120
• Device Lot Number: 06Z3110
• Other Device ID Number: 05020583101203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• 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: 00070 YR
• Patient Weight: 89