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

Model Number 10310

Device Problems Defective Device (2588); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the clamp was mixed up between the saline and return line.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported that the clamp was mixed up between the saline and return line.The customer declined to provide patient information, outcome or further procedural details.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: during follow-up with the customer, it was reported that since the non-conformity of the set was discovered right at the beginning of the procedure, the customer believes no hypervolemia was present.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the clamp was mixed up between the saline and return line.The customer declined to provide patient information, outcome or further procedural details.The collection 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 a3, e1, h6 and h10.Investigation: during follow-up with the customer, it was reported that since the non-conformity of the set was discovered right at the beginning of the procedure, the customer believes no hypervolemia was present.The product was not returned and therefore an evaluation could not be conducted.The customer indicated on the initial complaint form that the disposable set was unavailable.A photograph was submitted in lieu of the disposables set to aid in the investigation.The photo confirmed the alleged mis-assembly.The blue saline return roller clamp was identified on the return tubing line.The photo also appeared to show the patient as a juvenile male.There was evidence of blood in the inlet coil, but no evidence of fluid in the return line.The return line pinch clamp was verified in the closed position and appeared to be occluding the return line adequately.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to a mis-assembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.Specifically, the return saline roller clamp was incorrectly located on the return line as opposed to the saline line of the return coil.

• 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
• MDR Report Key: 12562543
• MDR Text Key: 275238716
• Report Number: 1722028-2021-00311
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: BK150251
• 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,Followup
• Report Date: 10/01/2021

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: 02/01/2022
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 2002283130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 12/12/2022
• Supplement Dates FDA Received: 01/07/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male