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

Catalog Number 000000000000010110

Device Problems Disconnection (1171); Device Displays Incorrect Message (2591)

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

Event Date 01/20/2015

Event Type  malfunction  

Event Description

The customer reported that during a collection procedure, they received multiple alarms.The operator checked inside the centrifuge and did some clean up but the alarm continued.While the operator was unloading the disposable set, they noticed the collection tubing was disconnected at the level of the chamber.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 (b)(4) report with their local authorities.

Manufacturer Narrative

Investigation: the disposable set was returned for investigation.Upon visual inspection it was noted that the tube to the wider end of the wbc chamber was detached.No tubing was noted inside the bond socket of the wbc chamber.Inspection of the solvent marks on the tubing indicated that the tubing had been inserted by only approximately 2mm into the chamber bond socket.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the cause of this failure is insufficient insertion of the tube into the chamber bond socket.Corrective action: an internal capa is in process for the disposable solvent application.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information in and to align with the reported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4600237
• MDR Text Key: 16631547
• Report Number: 1722028-2015-00088
• 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
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 000000000000010110
• Device Lot Number: 06W3223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• 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: 06/23/2014
• 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