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 09/04/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Investigation: two unused spectra optia disposable sets were received from the customer for investigation.The sets were visually inspected for kinks, occlusions, missing parts, misassembly and leaks which may have contributed to the failure of the disposable - none were found.The disposables were loaded onto a spectra optia machine without incident, passed all pressure tests and reached prime.The disposable sets were 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

Further investigation of the event reported by the customer has determined that duplicate information was provided to terumo bct.The information provided in the initial report for this event has been determined to be information that was also reported in mdr # 1722028-2015-00608 and 1722028-2015-00610.No event occurred for this report, therefore, there is no further information to provide.Please see mdr # 1722028-2015-00608 and 1722028-2015-00610 for investigation of that event.

• 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: 5142508
• MDR Text Key: 28037517
• Report Number: 1722028-2015-00579
• 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
• 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: 03Y3131
• 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
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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