MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA PLATELET PLASMA SET

Catalog Number 10400

Device Problems Use of Device Problem (1670); Insufficient Information (3190); Device Handling Problem (3265)

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

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.Investigation: per the customer, they did not agitate platelet bags prior to sampling.A terumo bct clinical specialist provided customer with information on proper platelet sampling technique.Problem seems to have been resolved upon implementation of proper sampling technique.Investigation is in process, a follow-up report will be provided.

Event Description

This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The platelet 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 h.6 and h.10.Investigation: per the customer, they did not agitate platelet bags prior to sampling.A terumo bct clinical specialist provided customer with information on proper platelet sampling technique.Problem seems to have been resolved upon implementation of proper sampling technique.The lot number was unknown, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Correction: clinical specialist provided customer with information on proper platelet sampling technique as it was established that the customer did not agitate platelet bags prior to sampling.The problem seems to have been resolved upon implementation of proper sampling technique.Root cause: the root cause was determined to be improper sampling technique where the customer did not agitate the platelet bags prior to sampling.

Event Description

This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The platelet 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 e.1 and h.10.Investigation: per the customer, they did not agitate platelet bags prior to sampling.A terumo bct clinical specialist provided customer with information on proper platelet sampling technique.Problem seems to have been resolved upon implementation of proper sampling technique.The lot number was unknown, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process, a follow-up report will be provided.

Event Description

This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA PLATELET PLASMA 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: 16352847
• MDR Text Key: 309431052
• Report Number: 1722028-2023-00045
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 02/10/2023

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 Catalogue Number: 10400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 06/14/2023; 07/19/2023
• Supplement Dates FDA Received: 07/07/2023; 07/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other