ELUTRA
Received Sep 1, 2016 · Event occurred Aug 9, 2016
Report 1722028-2016-00494 · MDR key 5923339
Device
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional 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.
Description of Event or Problem
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.