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

Catalog Number 000000000000010220

Device Problem Noise, Audible (3273)

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

The customer reported that they heard a 'weird' noise in the centrifuge during prime.The operator setup a new disposable set of the same lot and heard the same noise.They setup the procedure using a different lot and the problem was resolved.No medical intervention was necessary for this event.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

Additional evaluation method code used: sterilization process review investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Two sets were received for investigation.Set # 1 was a dry set.Visual inspection showed the set was assembled correctly.The set was loaded and passed pressure testing with no issues.No abnormal sounds were noted during testing.Set # 2 was received containing ac and saline.Visual inspection showed the set was assembled correctly.The set was loaded and passed pressure testing and ac/saline prime with no problems and no abnormal noises were noted.Root cause: using the available evidence, a misload is most likely the cause the abnormal noises in the centrifuge.If the loop¿s bearings are not placed completely into the holders of the centrifuge arm, centrifugal force can cause the braided loop portion of the tubing to hit against the inner basin wall while the centrifuge is spinning.This would cause the reported abnormal noises.The lack of evident damage on the sets can be explained because the procedures were halted during prime.Additional information: the customer's site was contacted to determine if the facility wanted re-training regarding the misload, the customer declined the re-training.

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 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: 4327230
• MDR Text Key: 5245765
• Report Number: 1722028-2014-00487
• 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
• Report Date: 11/19/2014

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: 03/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 03W3113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/30/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2014
• 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