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

Catalog Number 10110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: one used and one unused spectra optia disposable set were received from the customer for investigation.Upon visual inspection the following observation was noted: the used disposable contained blood throughout the cassette and channel.Upon further inspection the lower bearing had been detached from the lower loop sleeve and the lower bearing locating ears had been sheared off.Witness marks were present on the small shoulder of the lower bearing indicating that it was seated correctly into the lower bearing holder.In addition laceration marks were present on the lower loop sleeve and no witness mark was visible from the upper hex collar.The unused disposable 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.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure, the channel ring of the optia set became unwelded, which resulted in an unspecified amount of blood lost, and required a longer than expected hospitalization for the patient.Due to eu personal privacy protection laws, the patient information is not available from the customer.

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.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 is event based on additional investigational information.Root cause: review of the unused returned disposable set indicated that it was assembled correctly and had no kinks, occlusions or leaks which may have contributed to the reported problem.The returned disposables were loaded onto spectra optia machines and reached prime without incident.The cause for the reported incidents could not be conclusively determined.Evaluation of the returned used disposable found evidence, the shaved hex and the sleeve laceration marks, of a lower hex misload.

Event Description

The customer clarified that the patient had to wait longer until the new disposable set was loaded.Therefore, no medical intervention was required for this event.

Manufacturer Narrative

This report is being filed to provide additional information.Evaluation of the returned used disposable found that there were sleeve laceration marks and the ears shaved off.The bearing had witness marks, indicating correct seating in the lower bearing holder.However, there were no witness marks visible on the hex, which indicates that a hex misload was the cause of the leak.Additional information: the customer has been re-trained on the spectra optia loading procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: kristen cohen ; 10810 w collins ave; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 5142499
• MDR Text Key: 28037365
• Report Number: 1722028-2015-00578
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK140151
• 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: Followup,Followup
• Report Date: 09/14/2015

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: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/25/2015; 03/02/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization