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

Catalog Number 10116

Device Problems Therapeutic or Diagnostic Output Failure (3023); No Apparent Adverse Event (3189)

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported hemolysis in the plasma bag during the mononuclear cell (mnc) collection.Per the customer end run was the only option.The operator gathered the anticoagulant whole blood between inlet line and collect pump, then separated by centrifuge machine.The separated plasma color was normal.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.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.

Event Description

The customer reported hemolysis in the plasma bag during the mononuclear cell (mnc) collection.Per the customer end run was the only option.The operator gathered the anticoagulant whole blood between inlet line and collect pump, then separated by centrifuge machine.The separated plasma color was normal.Patient information and outcome are unknown at this time the collection set is not available for return because it was discarded by the customer.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.The pink plasma was due to spillover.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported hemolysis in the plasma bag during the mononuclear cell (mnc) collection.Per the customer end run was the only option.The operator gathered the anticoagulant whole blood between inlet line and collect pump, then separated by centrifuge machine.The separated plasma color was normal.Patient information and outcome are unknown at this time the collection set is not available for return because it was discarded by the customer.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: 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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT 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: 12122606
• MDR Text Key: 262512727
• Report Number: 1722028-2021-00228
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/06/2021

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: 02/01/2023
• Device Catalogue Number: 10116
• Device Lot Number: 2102083230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 05/20/2022; 06/22/2022
• Supplement Dates FDA Received: 06/06/2022; 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2021
• 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