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

Catalog Number 10310

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

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

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that while performing a continous mononuclear cell (cmnc) collection procedure on spectra optia, they received an 'interface took too long to establish' alarm.The customer contacted terumo bct for troubleshooting.The customer noted that the saline rollerclamp on the inlet line was not completely closed and there was only approximately 100 mls of saline missing from the anticoagulent (ac) bag.The support specialist instructed the operator to close the inlet saline roller clamp completely and customer continued the procedure without any further issues.The customer reported that the patient did not experience any problems during the procedure.The customer declined to provide patient information.The cmnc 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.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the customer, the operator was not concerned about the additional fluid that had been inadvertently administered to the patient due to the incomplete closure of the saline roller clamp as the patient was in stable condition.Root cause: the open saline clamp was determined to be due to user error.

Event Description

The customer did not respond to multiple attempts to obtain patient identifier, age, gender, weight and outcome, along with any procedural details including the total blood volume (tbv) and fluid balance of the patient.

Manufacturer Narrative

This report is being filed to provide updated information.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is in-process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w.collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7454951
• MDR Text Key: 107086873
• Report Number: 1722028-2018-00105
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• 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: 04/24/2018

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: 03/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1803033130
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 06/05/2018; 07/25/2018; 09/27/2018
• Supplement Dates FDA Received: 06/08/2018; 07/25/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2018
• 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