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

Model Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 06/09/2023

Event Type  malfunction  

Event Description

The customer called and reported that the interface was not properly establishing during a therapeutic plasma exchange (tpe) on a lung transplant patient.The customer reported that the lab had problems with the labs and that the plasma was red tinged in the centrifuge.They said that they would need to call the physician at the site to determine if they could continue the run.They checked the fluids and the correct fluids were attached on each spike.They paused the procedure with a kvo and asked how long they could keep the machine running with the patient on it while they contacted the physician.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: the customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.The lot number was not provided, 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

The customer called and reported that the interface was not properly establishing during a therapeutic plasma exchange (tpe) on a lung transplant patient.The customer reported that the lab had problems with the labs and that the plasma was red tinged in the centrifuge.They said that they would need to call the physician at the site to determine if they could continue the run.They checked the fluids and the correct fluids were attached on each spike.They paused the procedure with a kvo and asked how long they could keep the machine running with the patient on it while they contacted the physician.Patient information and outcome are unknown at this time.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 h.6 and h.10.Investigation: the customer did not respond to multiple attempts to obtain information for the investigation such as patient (recipient) information, recipient outcome, procedural details and lot information.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.The residual total risk is determined to be low.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

Event Description

The customer called and reported that the interface was not properly establishing during a therapeutic plasma exchange (tpe) on a lung transplant patient.The customer reported that the lab had problems with the labs and that the plasma was red tinged in the centrifuge.They said that they would need to call the physician at the site to determine if they could continue the run.They checked the fluids and the correct fluids were attached on each spike.They paused the procedure with a kvo and asked how long they could keep the machine running with the patient on it while they contacted the physician.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 17229480
• MDR Text Key: 318132649
• Report Number: 1722028-2023-00224
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other