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

Catalog Number 10110

Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Use of Device Problem (1670); Incomplete or Inadequate Connection (4037)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

The run data file (rdf) was analyzed for this event.Based on the rdf analysis,the spectra optia system operated as intended.Investigation: a service call was placed and a terumo bct technician performed a machine checkout at the customer site.An autotest was successfully performed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a mononuclear cell (mnc) collection procedure, the register nurse noted a 'minimal' blood leak and air in the blood warmer tubing line connected to the return tubing line.The procedure was aborted without rinse back and the patient was disconnected.The patient is reported in stable condition.(b)(6).The spectra optia collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: based on the information available, possible causes for air entering the set include but are not limited to: poor blood warmer luer connection: operator did not fully connect the blood warmer luer connection.Disposable luer defect did not allow full connection between return line and blood warmer.The blood warmer luer connection being higher than 20 inches above the return access allowing air to enter the tubing.

Manufacturer Narrative

This report is being filed to provide additional information and a correction.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A run data file (rdf) analysis also reflected no return line air detector (rlad) alarms occurred at any point in the procedure.The machine operated as intended and is safe to use.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer stated that they did not observe air past the connection of the blood warmer tubing line connected to the return tubing line going towards the patient.Investigation is still in process.A follow-up report will be provided.

• 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: 7185968
• MDR Text Key: 97785571
• Report Number: 1722028-2018-00008
• Device Sequence Number: 1
• Product Code: GKT
• 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,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 10110
• Device Lot Number: 1708303330
• Other Device ID Number: 05020583101104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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: 00061 YR
• Patient Weight: 81