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

Catalog Number 12220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Hypersensitivity/Allergic reaction (1907); Cough (4457)

Event Date 01/17/2023

Event Type  Injury  

Event Description

The customer reported that the patient undergoing tpe procedure had a severe episode of cough.The patient had a presenting diagnosis of transplant rejection.Prior to the procedure, the patient was described as stable.It is unknown if the patient was on ace inhibitors.5 minutes into the tpe procedure she had a severe cough and chest pain.The nurse paused the machine and administered 25mg benadryl iv and 500mg solu-medrol (an anti-inflammatory glucocorticoid) by order of the nephrologist.The administration of medication was unplanned and in response to the patient reaction.The doctor ordered the procedure to be stopped and for the patient to be transferred to er because the cough continued.The patient was disconnected and transferred to er for a ct scan and x-rays by the rapid response team.The current patient status after admission to er for observation was described as vital signs stable (vss the exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.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 4.8%.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 investigation and conclusion: a definitive root cause for the patient's reaction could not be determined.Based on customer's statements about the allergic reaction, possible causes for the patient's reaction include but are not limited to the patient's pre-existing condition and/or medication, an allergy to replacement solution and/or patient sensitivity to eto.

• 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: 16354589
• MDR Text Key: 309307392
• Report Number: 1722028-2023-00049
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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
• Report Date: 02/10/2023

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: 12220
• Device Lot Number: 2207293230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2022
• 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
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Hispanic