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

Catalog Number 10315

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005); No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer that during a continuous mononuclear cell (cmnc) collection procedure they had a "patient's fluid balance may be 30% higher than reported" alarm.The only option was to disconnect the patient.The procedure was being performed with a child with 570ml of tbv.There were some inlet low pressure alarms and platelet accumulation was observed in the reservoir.Patient id, age and outcome are not available at this time.The disposables 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

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 the patient fluid balance was within acceptable limits.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer that during a continuous mononuclear cell (cmnc) collection procedure they had a "patient's fluid balance may be 30% higher than reported" alarm.The only option was to disconnect the patient.The procedure was being performed with a child with 570ml of tbv.There were some inlet low pressure alarms and platelet accumulation was observed in the reservoir.Patient id, age and outcome are not available at this time.The disposables 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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 12287990
• MDR Text Key: 267229646
• Report Number: 1722028-2021-00260
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: 08/06/2021

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: 09/01/2022
• Device Catalogue Number: 10315
• Device Lot Number: 2009013130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 8