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

Catalog Number 10315

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

Patient Problems Erythema (1840); High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection procedure, the patient remained hemodynamically stable.At the end of the procedure, the patient had some erythema.The patient told the doctor that she had the reddening skin during the procedure as well.During the procedure, the patient what appeared to be a mild citrate reaction, with tremors and cold, that did not require any medical intervention.24 hours after the procedure, the doctor reported that the patient had hyperemia, tachycardia, and high blood pressure.The symptoms presented were: tingling in the feet, tremors, diffuse erythema, sinus tachycardia, mild hypertension.There was no fever or respiratory changes.During the collection, calcium and magnesium replacement were performed.The attending physician said that the patient began to experience these reactions during collection and remained with erythema, tachycardia and hypertension until she visited and the doctor prescribed an antihistamine for her.The next day, the doctor said that the erythema has already improved.Per the customer, filgrastim 300 mcg 1 ampoule 12 / 12h was used from the 16th to the 20th of october plus plerixafor on the 19th of october was used for mobilization.Patient identifier, age, and weight are not available at this time.The disposable 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 b.5.Investigation is in process.A follow up report will be provided.

Event Description

Per the customer, the antihistamine that was prescribed for the patient's reactions was hixizine 1 tablet 25 mg and the calcium and magnesium replacement were performed per procedure.

Manufacturer Narrative

This report is being filed to provide corrected information in e.1 and additional information in h.6 and h.10.Root cause: a definitive root cause for the patient's reaction could not be determined.Based on customer's statements about the allergic reaction and the literature review, possible causes for the patient's reaction include but are not limited to: - an allergy to replacement solution - patient sensitivity to citrate - patient sensitivity to eto - side effects related to mobilization therapy.

Event Description

Per the customer, the patient showed improvement in the symptoms described in the occurrence post medical intervention.

Manufacturer Narrative

Investigation : 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 disposable complaint history search for lot 1910313230 found no other reports of allergic reactions.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Sterilization and aeration were successfully completed.This product has been validated to achieve less than 6mg eto, meeting the requirements of iso 10993-7 prior to release and less then 1ppm in the collect bag at time of use.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10830335
• MDR Text Key: 216136226
• Report Number: 1722028-2020-00510
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 10315
• Device Lot Number: 1910313230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00056 YR
• Patient Weight: 56