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

Catalog Number 000000000000010110

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Material Twisted/Bent (2981)

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

Event Date 10/07/2014

Event Type  malfunction  

Event Description

The customer reported a leak during a mononuclear cell (mnc) collection procedure.46 minutes into the procedure, they received a 'leak detected in centrifuge' alarm.The operator paused the procedure and noted the 4-lumen tubing between the upper and lower bearing was twisted and shredded.The operator disconnected the patient and a new disposable set was loaded.No medical intervention was necessary for this event.Due to eu personal data protection laws, patient information is not available from the customer.Patient gender and weight were obtained from the run data files.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

Investigation: per the customer, the operator increased the amount of acd-a within acceptable limits for prolonged collection time and the patient did not require a blood prime.The disposable set was returned for investigation.Upon visual inspection of the set the following observations were noted:-the upper and lower bearings had witness marks to suggest correct loading by customer-the lower bearing was disconnected from the centrifuge collar line and the locating ears were sheared off-there was a large laceration through the centrifuge collar line 4.5 cm from the collar and an additional wear mark was observed 2 cm from the collar.-the braid was noted to be twisted.-the 4-lumen tubing was also noted to be severely twisted resulting in a tear and leak from the collect/inlet line 2.5 cm below the centrifuge collar line in the area covered by the braid.The run data file (rdf) was analyzed for this event.Root cause: the part evaluation, specifically the laceration through the centrifuge collar(sleeve), indicates that the lower hex was not fully seated or locked into the hex holder.The ¿leak was detected in centrifuge¿ alarm occurred 41 minutes into the procedure.There were no unusual signals or any additional issues throughout the procedure.The system operated as intended by alerting the operator to a leak in the centrifuge.

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.

• 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: 4218209
• MDR Text Key: 4973728
• Report Number: 1722028-2014-00434
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K132429
• 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
• Report Date: 10/07/2014

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: 01/01/2016
• Device Catalogue Number: 000000000000010110
• Device Lot Number: 01W3213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 10/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• 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
• Patient Weight: 52