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

Catalog Number 000000000000010110

Device Problems Increase in Pressure (1491); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 02/26/2014

Event Type  malfunction  

Event Description

The customer reported that they received a 'centrifuge pressure went over the limit' alarm during the fourth collection cycle of the procedure.Per the customer, the end products were transfusable.No safety event occurred with the patient.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: per the customer, upon visual inspection, small damages were detected on disposable set.The disposable set was not available for return and investigation.Root cause: the root cause was undetermined.This disposable set was unavailable for specific root cause analysis by terumo bct quality assurance.Possible causes include but are not limited to:- obstruction or air block inside tubing set- channel on tubing set is not properly installed- channel loop is twisted or rbc line into channel is kinked- defective or mis-calibrated centrifuge pressure sensor- defective control board a centrifuge pressure may occur as a result of a disposable defect, or a misloaded disposable set.

Manufacturer Narrative

Investigation: the disposable set was available for return and investigation.The lower bearing had a witness mark to indicate correct loading.The lower bearing was detached from the centrifuge collar line (aka lower sleeve).One of the locating ears was sheared off and the sleeve was damaged around this area.There was a small damage mark on the sleeve under the hex collar.The device history record was reviewed.All sut samples passed testing, there were no issues noted in loop sleeve assembly, and there were no systemic quality issues noted.A review of the lot for similar reports was carried out, none have been reported.Root cause: a centrifuge pressure high alarm is generated when the centrifuge channel pressure is high, as detected by the centrifuge pressure sensor (cps).The alarm can manifest as a result of a disposable defect or a misloaded disposable set.This investigation analyzed there turned part and the findings are consistent with a manufacturing error where the sleeve ears were not snapped in on the lower bearing.

Manufacturer Narrative

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

• 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: 3787710
• MDR Text Key: 17930169
• Report Number: 1722028-2014-00155
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131744
• 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
• Report Date: 04/08/2014

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 Expiration Date: 09/01/2015
• Device Catalogue Number: 000000000000010110
• Device Lot Number: 09V3125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/02/2014; 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• 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