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

Catalog Number 12220

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer contacted terumo bct customer support and reported that during a therapeutic plasma exchange (tpe) procedure they observed blood going into the waste bag.The operator was 17 minutes into the tpe procedure for a thrombotic thrombocytopenic purpura (ttp) patient and she received the alarm "aim system detected rbc interface near top of channel".Ldh and other testing was not able to be run due to the high levels of hemolysis.The operator went ahead and decreased the hematocrit all the way to 14%, she did not troubleshooted correctly and incorrectly increased the interface even more.She reported she disable the aim system to not hear the sound.Customer support asked her to increase the hematocrit back to the original value and then increased it to 24% and then 27% to push the cells down.The physician at the customer site was by the bed side and explained that the nurse did the wrong troubleshooting.Customer support explained that it is crucial to read the troubleshooting, so they can do it correctly.The dr.Decided to rinseback and ask the nurse to set up again and start over.Support went over the troubleshooting with the physician.Per the customer, the patient was also connected to an extracorporeal membrane oxygenation (ecmo) machine.Patient information and outcome are unknown at this time the collection set is not available because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide investigation: 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 physician confirmed the hemolysis was due to the patient¿s progression disease.No further reporting will be provided as this does not represent a reportable event.Root cause: a root cause assessment was performed for this complaint.Based on the information provided by the physician, the root cause of the hemolysis was determined to be related to the patient¿s progression disease.

Event Description

The customer contacted terumo bct customer support and reported that during a therapeutic plasma exchange (tpe) procedure they observed blood going into the waste bag.The operator was 17 minutes into the tpe procedure for a thrombotic thrombocytopenic purpura (ttp) patient and she received the alarm "aim system detected rbc interface near top of channel".Ldh and other testing was not able to be run due to the high levels of hemolysis.The operator went ahead and decreased the hematocrit all the way to 14%, she did not troubleshooted correctly and incorrectly increased the interface even more.She reported she disable the aim system to not hear the sound.Customer support asked her to increase the hematocrit back to the original value and then increased it to 24% and then 27% to push the cells down.The physician at the customer site was by the bed side and explained that the nurse did the wrong troubleshooting.Customer support explained that it is crucial to read the troubleshooting, so they can do it correctly.The dr.Decided to rinseback and ask the nurse to set up again and start over.Support went over the troubleshooting with the physician.Per the customer, the patient was also connected to an extracorporeal membrane oxygenation (ecmo) machine.Patient information and outcome are unknown at this time the collection set is not available 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: 18445961
• MDR Text Key: 332605876
• Report Number: 1722028-2024-00005
• 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
• Report Date: 01/04/2024

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: 12220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/11/2024
• 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