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

Model Number 10310

Device Problems Device Misassembled During Manufacturing /Shipping (2912); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: one unused optia set was received for investigation.Visual inspection confirmed the red roller clamp was assembled on the ac line instead of the saline line of the inlet coil.The blue roller clamp was noted to be on the correct line.The set was further inspected for anymore misassemblies, kinks or missing parts and none were found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a misassembled saline roller clamp on a therapeutic plasma exchange (tpe) procedure.Patient information is unknown at this time.Per the customer there was no medical intervention or serious injury to the patient.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that this instance would not exceed 20% reportable limit for hypervolemia and there was bi risk of free flow of saline to the patient.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported a misassembled saline roller clamp on a therapeutic plasma exchange (tpe) procedure.Patient information is unknown at this time.Per the customer there was no medical intervention or serious injury to the patient.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 12180969
• MDR Text Key: 264047826
• Report Number: 1722028-2021-00237
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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: 10/01/2022
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 2010263130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other