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

Catalog Number 10225

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem Urticaria (2278)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: during the virtual saline wash it was suggested by a tbct representative to use inlet flow of less than 142/min.Per the customer, they did replace with albumin.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that when performing a therapeutic plasma exchange (tpe) procedure, a patient presented with a urticarial reaction.Per the customer, they used antihistamine to prevent a reaction.100mg of hydrocortisone, 1 ampoule of diphenhydramine.In the second session they swapped the albumin of grifols for albumin of alburex, but the reaction persisted.Before start third session they reported the situation, terumo bct support proposed to wash with s.Salina.The premedication was kept, however, and there was no further reaction.Two other sessions have already been successfully performed following this.Patient information is 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

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.3.Investigation: during the virtual saline wash it was suggested by a tbct representative to use inlet flow of less than 142/min.Per the customer, they did replace with albumin.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that when performing a therapeutic plasma exchange (tpe) procedure, a patient presented with a urticarial reaction.Per the customer, they used antihistamine to prevent a reaction.100mg of hydrocortisone, 1 ampoule of diphenhydramine.In the second session they swapped the albumin of grifols for albumin of alburex, but the reaction persisted.Before start third session they reported the situation, terumo bct support proposed to wash with s.Salina.The premedication was kept, however, and there was no further reaction.Two other sessions have already been successfully performed following this.Patient information is 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

Investigation: during the virtual saline wash it was suggested by a tbct representative to use inlet flow of less than 142/min.Per the customer, they did replace with albumin.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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: a root cause assessment was performed for this complaint.Root cause for the patient's reactions were related to an allergy to the ethylene oxide used to sterilize the disposable set.The patient had a second allergic reaction despite the switch in the albumin replacement fluid from grifols to alburex, manufactured by csl plasma.The saline wash in the third procedure seemed to have addressed this issue.

Event Description

The customer reported that when performing a therapeutic plasma exchange (tpe) procedure, a patient presented with a urticarial reaction.Per the customer, they used antihistamine to prevent a reaction.100mg of hydrocortisone, 1 ampoule of diphenhydramine.In the second session they swapped the albumin of grifols for albumin of alburex, but the reaction persisted.Before start third session they reported the situation, terumo bct support proposed to wash with s.Salina.The premedication was kept, however, and there was no further reaction.Two other sessions have already been successfully performed following this.Patient identifier and age were not provided by the customer.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 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: 12348530
• MDR Text Key: 267506182
• Report Number: 1722028-2021-00272
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 10225
• Device Lot Number: 2008043130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2020
• 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; Other
• Patient Sex: Male
• Patient Weight: 54 KG