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

Catalog Number 10226

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, the patient's neck, legs and abdomen appeared with a wind-ike rash at 16:38.The operator gave the patient 10% calcium gluconate 20ml orally and 5mg hexadecadrol by intravenous injection per physician order.The operator reported the symptoms relieved at 16:55.Prior to the procedure, the patient was administered 10% calcium gluconate 20ml.The disposable set is not available for return for evaluation.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.

Event Description

The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, the patient's neck, legs and abdomen appeared with a wind-ike rash at 16:38.The operator gave the patient 10% calcium gluconate 20ml orally and 5mg hexadecadrol by intravenous injection per physician order.The operator reported the symptoms relieved at 16:55.Prior to the procedure, the patient was administered 10% calcium gluconate 20ml.The disposable set is not available for return for evaluation.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 e.1 and e.3.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, d.2b, e.1, h.6 and h.10.Investigation: based on literature reference, therapeutic apheresis: a physician's handbook, allergic reactions are usually associated with replacement procedures that include blood components but sensitivity to disposable tubing sterilized with ethylene oxide can also be associated with allergic reactions.A disposable complaint history search was performed for this lot and found a total of 4 occurrences were reported across 2 complaint records from the same customer for similar issues worldwide.See mdr 1722028-2022-00274, mdr 1722028-2022-00275, mdr 1722028-2022-000277, mdr 1722028-2022-00279.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.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.The system operated as intended and the procedures were run without incident.There were no signals or alarms in the rdf that would indicate issues during the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.Root cause: a root cause assessment was performed for this complaint.Based on customer's statements about the allergic reaction and the literature review, possible causes for the patient reaction includes but is not limited to an allergy to replacement solution and/or patient sensitivity to eto.

Event Description

The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, the patient's neck, legs and abdomen appeared with a wind-ike rash at 16:38.The operator gave the patient 10% calcium gluconate 20ml orally and 5mg hexadecadrol by intravenous injection per physician order.The operator reported the symptoms relieved at 16:55.Prior to the procedure, the patient was administered 10% calcium gluconate 20ml.The disposable set is not available for return for evaluation.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: 15252515
• MDR Text Key: 298171678
• Report Number: 1722028-2022-00277
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2022

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 Expiration Date: 10/01/2023
• Device Catalogue Number: 10226
• Device Lot Number: 2110013230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 05/04/2023; 05/19/2023
• Supplement Dates FDA Received: 05/08/2023; 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2021
• 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; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 56 KG