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

Catalog Number 12320

Device Problems Misassembled (1398); Device Displays Incorrect Message (2591); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per operator,the patient did not receive any fluid.The customer provided a photograph in lieu of the disposable set.The photo confirmed the return saline roller clamp was misassembled onto the return line tubing.The presence of fluid was verified within the tubing.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that they received a "return pressure high" alarm shortly after starting a continuous mononuclear cell (cmnc) collection on a spectra optia device.Per the customer the saline roller clamp was on the return line instead of the return saline line.After having localized the failure, the customer was able to continue the procedure with the help from a hemostat clamp.No medical intervention was required for this event.Per the customer the device did not contribute any injury to the patient (donor).Patient information and outcome are unknown at this time.The spectra optia idl set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in 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 customer confirmedthe patient did not receive any additional fluid beyond what the system delivered, therefore,there is no concern for hypervolemia for this event.A review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.The terumo bct manufacturing manager for disposable table top assembly was made aware ofthis issue on 4oct2019.Root cause: the cause of this defect was related to a misassembly, where the assemblerneglected to follow the appropriate manufacturing operating procedure of the disposable setduring manufacturing.

Event Description

The customer confirmed the patient did not receive any additional fluid beyond what thesystem delivered.No medical intervention was required for this event.Due to eu personal data protection laws, the patient information is not available from thecustomer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9099225
• MDR Text Key: 165234072
• Report Number: 1722028-2019-00276
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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: 04/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1904083231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other