MAUDE Adverse Event Report: TERUMO BCT ELUTRA; ELUTRA SET

Catalog Number 70800

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: the customer set up a new (unexpired) kit and continued with the procedure without incident.The elutra operator's manual directs the operator to check the expiration date on the disposable tubing set package, before loading the tubing set.No patient was involved and the product was not used.Terumo bct followed-up with thecustomer regarding the use of the expired set.The customer confirmed that no product was collected.The customer also said he checked his inventory for any other remaining unused expired kits to be discarded.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr for this lot.Root cause: root cause was determined to be a user error in which the customer initially attempted to use an expired set.

Event Description

The customer reported that they received an alarm during a setup for an elutra procedure.While the operator was troubleshooting, he noticed the elutra set expired in june2015.The expired set was discarded and a new elutra set was setup for the procedure.This is a laboratory device.No patient was connected at the time of the event.No patient information is reasonably known.The elutra collection set is not available for return because it was discarded by the customer.

• Brand Name: ELUTRA
• Type of Device: ELUTRA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5923339
• MDR Text Key: 54463134
• Report Number: 1722028-2016-00494
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: 70800
• Device Lot Number: 07W15290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2014
• 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