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

Catalog Number 10120

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during rinseback of a collection procedure, they inadvertently left both saline roller clamps open instead of only one on the access line.Patient information and outcome are not available at this time.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to correct the date of the event.The date that was provided in the initial report should have been (b)(6) 2015.I 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.

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 there is a likely potential for death or serious injury associated with event based on additional investigational information.The run data file (rdf) was analyzed for this event.Signals in the rdf indicate that the fluid balance reported on the spectra optia system +9.9ml and the patient's total blood volume is 3857ml.The worst-case fluid balance for the patient was calculated to be 96.9% at the end of the procedure.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Terumo bct sales representative followed-up with the customer.The customer was informed of the correct procedure to which the customer stated that she would be more attentive to the messages on the screens in the future.Root cause: the cause for the opened clamps during the rinse back procedure was an oversight by the operator.

Event Description

The customer did not respond to multiple attempts to obtain patient information.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5318186
• MDR Text Key: 34885206
• Report Number: 1722028-2015-00668
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK151368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2015

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 Catalogue Number: 10120
• Device Lot Number: 05Y3120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2015; 02/09/2016; 03/04/2016; 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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