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

Catalog Number 12320

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Detachment of Device or Device Component (2907); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used optia idl collection bag containing blood was returned to terumo bctfor investigation.Visual inspection confirmed the collection tubing line was detached from the collection bag bond socket.Additionally, two hemostat clamps were returned attached to the collection bag.A blue slide clamp was used to close the collection line tubing.The blue clamp was attached at the end of the tubing creating difficulty when determining presence of solvent on the tubing.However, minimal solvent on the tubing was identified.Based on the evidence found in the set investigation, the root cause of the reported failure was due to insufficient solvent used to bond the tubing into the bond socket.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported a leak from the spectra optia mononuclear cell (mnc) collection bag.The operator stated that this was the last of 3 non-stimulated collections for a patient with prostate cancer.The operator stated that the collect line detached from the base of the collection bag while stripping the collected product in the line up towards the bag.The customer reported that they were not able to infuse this collection back to the patient as planned.The patient was rescheduled for another unplanned collection on (b)(6) 2019.Per the customer the patient is reported in stable condition.

Manufacturer Narrative

This report is being filed to provide in corrected information isprovided in h.1.Investigation: further evaluation of this event has determined that the device did not causeor contribute to a death or serious injury, nor is there a likely potential for death or serious injuryassociated with this event based on additional investigational information.The loss of productrequired an additional collection that did not require medication as this was a non-stimulateddonor.Correction: manufacturing staff were made aware of the reported issure and were retrained tothe appropriate procedures.Root cause: based on the returned part investigation, the root cause was determined to beinsufficient solvent applied on the tubing during the manufacturing process by the assemblerwhen bonding the tubing into the mating socket.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8666480
• MDR Text Key: 146977071
• Report Number: 1722028-2019-00131
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1903153330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 121