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

Catalog Number 000000000000010110

Device Problem Disconnection (1171)

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

Event Date 10/28/2014

Event Type  malfunction  

Event Description

The customer reported that they noticed the collect tubing disconnected from the collection chamber at the beginning of a collection procedure, when saline had leaked out of the set onto the floor.No medical intervention was necessary for this event.Due to eu personal data protection laws, the patient information is not available from the customer.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr related to quality issues with assembly.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the spectra optia set (containing ac and saline) was received for investigation.Visual inspection of the set confirmed that the tube from the broad (loop) end of the chamber was torn at the bond socket exit.Tubing was present in the bond socket indicating that the failure was not related to in adequate bonding.Some scratches/damage were also noted on the chamber body.A photograph was also sent, and it showed the same as above.Root cause: based on the part evaluation findings and the early stage at which the failure occurred, it is concluded that the leak occurred because the chamber was not loaded correctly into the bracket in the centrifuge.

Manufacturer Narrative

Additional information: training regarding the loading of centrifuge disposables, was conducted for the nursing team at the customer site.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4346286
• MDR Text Key: 5204566
• Report Number: 1722028-2014-00492
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: 000000000000010110
• Device Lot Number: 03W3225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other