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

Catalog Number 10110

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a collection procedure, the connector close to the channel of the optia set disconnected which resulted in a longer than expected hospitalization for the patient.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.

Manufacturer Narrative

(b)(4).The disposable set was returned for investigation.The customer returned an unused set for investigation.The set was visually inspected for kinks, occlusions, missing parts, misassembly and leaks which may have contributed to the failure of the disposable, none were found.The disposable was loaded onto a spectra optia machine without incident, passed all pressure tests and reached prime.The disposable set was assembled correctly.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with event based on additional investigational information.Root cause: a definitive root cause could not be determined.Per the part evaluation, there were no identified manufacturing issues associated with the returned set.Therefore no specific root cause could be determined.Based the investigation results, the patient¿s procedure was delayed only for the time span to unload the existing disposable set and reload a new one.Per the 'first aid' definition, this delay not considered medical intervention.

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 COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: robbin crafe ; 10810 w collins ave; lakewood, CO 80215 ; 3032392282
• MDR Report Key: 5207337
• MDR Text Key: 30599560
• Report Number: 1722028-2015-00609
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK140191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 10110
• Device Lot Number: 03Y3118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• 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: 03/18/2015
• 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): Hospitalization