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

Catalog Number 000000000000010220

Device Problem Leak/Splash (1354)

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

Event Date 12/04/2014

Event Type  malfunction  

Event Description

The customer reported at the beginning of an exchange procedure, they received an 'obstacle in centrifuge or presence of an object' alarm.The operator also noticed blood had leaked in the centrifuge.Due to eu personal data protection laws, the patient information is not available from the customer.Terumo bct is awaiting return of the disposable set for evaluation.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a definitive root cause could not be determined.No concerns were noted with the set.Based on the customer's report of the timing and description of the event, it is possible that the alarm was caused by, but not limited to, a centrifuge pressure sensor malfunction, a centrifuge door malfunction, or a set that was not properly loaded.

Manufacturer Narrative

Investigation: the disposable set was received for investigation.Visual inspection showed no blood or fluid in the set.The set passed the pressure test and no defects of the channel or set was noted.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

The incident description has been revised to reflect an updated incident description provided from the customer upon further clarification and follow-up.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that before the start of priming, the machine alarmed "obstacle in the centrifuge or presence of an object." they were not able to start priming and had to change the kit to continue the procedure.

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 appropriately.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4358349
• MDR Text Key: 5204286
• Report Number: 1722028-2014-00515
• 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,Followup
• Report Date: 12/04/2014

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: 06/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 06W3311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/16/2015; 02/10/2015; 03/30/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2014
• 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