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 Itching Sensation (1943)

Event Date 07/03/2022

Event Type  Injury  

Event Description

The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, the patient felt slight pruritus on the face at 11:00.The operator gave the patient 10% calcium gluconate 20ml orally and 3mg hexadecadrol per physician order by intravenous injection.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

Investigation is in process.A follow up report will be provided.

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 felt slight pruritus on the face at 11:00.The operator gave the patient 10% calcium gluconate 20ml orally and 3mg hexadecadrol per physician order by intravenous injection.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: investigation: 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.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.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of 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.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.A disposable complaint history search was performed for this lot and found a total of 3 occurrences reported from the same customer (in this complaint record) for similar issues worldwide.Mdr 1722028-2022-00276 and mdr 1722028-2022-00278.The third occurrence was not reportable.Root cause: a root cause assessment was performed for this complaint.Based on customer's statements about the patient reactions possible causes include but are not limited to: an allergy to replacement solution and/or patient sensitivity to eto patient disease state and/or patient sensitivity to anticoagulant.

Event Description

The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, the patient felt slight pruritus on the face at 11:00.The operator gave the patient 10% calcium gluconate 20ml orally and 3mg hexadecadrol per physician order by intravenous injection.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: 15252789
• MDR Text Key: 298166795
• Report Number: 1722028-2022-00278
• 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: 24 YR
• Patient Sex: Female
• Patient Weight: 65 KG