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

Catalog Number 4122201

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

Patient Problems Itching Sensation (1943); Cough (4457)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The device was found to be operating as expected.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Blood warmer tubing lot# 32085432 investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during a red blood cell exchange (rbcx) procedure the patient had a blood reaction at the 2nd to last unit.The customer reported that the patient started coughing and complaining of a itchy throat and they stopped the procedure.The physician was notified and the patient was given benadryl 25 mg iv.Patient is in stable condition and the customer did a post reaction work up.Result are not available at this time.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported to terumo bct customer support that during a red blood cell exchange (rbcx) procedure the patient had a blood reaction at the 2nd to last unit.The customer reported that the patient started coughing and complaining of a itchy throat and they stopped the procedure.The physician was notified and the patient was given benadryl 25 mg iv.Patient is in stable condition and the customer did a post reaction work up.Result are not available 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 investigation: the run data file (rdf) was analyzed for this event.The device was found to be operating as expected.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Blood warmer tubing lot# 32085432 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.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The device was found to be operating as expected.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Blood warmer tubing lot# 32085432 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.

Event Description

The customer reported to terumo bct customer support that during a red blood cell exchange (rbcx) procedure the patient had a blood reaction at the 2nd to last unit.The customer reported that the patient started coughing and complaining of a itchy throat and they stopped the procedure.The physician was notified and the patient was given benadryl 25 mg iv.Patient is in stable condition and the customer did a post reaction work up.Result are not available at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The device was found to be operating as expected.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Blood warmer tubing lot# 32085432 a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of (b)(4)%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Root cause: review of the dlog and associated aim images does not show a clear root cause for the occurrence of air in the blood warmer tubing.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * luer connection from the return line to the blood warmer is placed too high * luer connection from the return line to the blood warmer is not tightly closed * blood warmer equipment creates outgassing in the tubing when warming of the fluid passing through the warmer such as cold replacement fluid * clumping in the channel connector a root cause assessment was performed for the allergic reactions.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * hypersensitivity to the ethylene oxide used to sterilize the disposable set.* hypersensitivity to the components inside the disposable set.* patient¿s underlying disease state or sensitivity to the apheresis procedure.A root cause assessment was performed for the clumping identified in the dlog.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.* activation of platelets because of the patient's physiology.

Event Description

The customer reported to terumo bct customer support that during a red blood cell exchange (rbcx) procedure the patient had a blood reaction at the 2nd to last unit.The customer reported that the patient started coughing and complaining of a itchy throat and they stopped the procedure.The physician was notified and the patient was given benadryl 25 mg iv.Patient is in stable condition and the customer did a post reaction work up.Result are not available 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: 18173723
• MDR Text Key: 328566838
• Report Number: 1722028-2023-00384
• 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,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4122201
• Device Lot Number: 2308093241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 11/21/2023; 04/19/2024; 05/08/2024
• Supplement Dates FDA Received: 12/12/2023; 05/06/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2023
• 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): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 75 KG