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); Discomfort (2330)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine that the customer site.An auto test and a saline run were successfully performed.Per the customer, no saline rinse was performed prior to the procedure.However,it is advisable from the manufacturer to perform a saline rinse prior to the procedure.Per customer follow up, it was found that the test for immunoglobin e (ige) antibodies and anti- ethylene oxide (eto) antibodies was done four days after the initial reaction of the patient and it tested negative.The customer believed that eto did not cause the patient reaction.As per terumo bct's certificate of analysis (coa), the amount of eto in the disposable set is validated to be < 6 mg.Journals recommended to the customer in relation to ethylene oxide (eto) sensitization are: transfusion.1987 jan-feb; 27 (1): 90-3."sensitization of repeat plasmapheresis donors to ethylene oxide gas." dolovich j, sagona m, pearson f, buccholz d, hiner e, marshall c.N engl j med.1986 nov 6; 315 (19): 1192-6."allergic reactions in healthy plateletpheresis donors caused by sensitization to ethylene oxide gas." leitman sf, boltansky h, alter hj, pearson fc, kaliner ma.According to "therapeutic apheresis: a physician's handbook," adverse events occur during therapeutic procedures with a frequency of 4.8%.Respiratory distress incidents occur in 0.3% of procedures.Allergic reactions are usually associated with replacement regimens that include blood components, but they can also be caused by medications, hydroxyethyl starch, or sterilization of disposable tubing with ethylene oxide.In this case, the customer confirmed that they were fifteen minutes into the depletion procedure when the patient developed the adverse reaction.Allergic symptoms may include hives, dyspnea, wheezing, hypotension,tachycardia, facial swelling or flushing, and burning eyes.Mild allergic reactions may be treated with a dose of diphenhydramine through an iv push.Symptoms of anaphylaxis may be alleviated by subcutaneous or intramuscular administration of epinephrine.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 14 minutes into a red blood cell exchange (rbcx) procedure on a spectra optia device, a sickle cell anemia patient experienced a reaction.The customer stated that after processing about 545 mls of blood, the patient complained of 'chest tightness' and stated that 'she felt uncomfortable earlier also but did not mention anything about it'.Per the customer, they stopped the procedure immediately and after notifying the physician, the decision was made to terminate the procedure.Per physician's orders, the patient was administered 25 mgs of iv benadryl and 20 mgs of iv pepcid to manage the symptoms of the reported reaction.Per the customer, the patient is reported in the stable condition.The customer declined to provide patient identifier (id) and age.The red blood cell exchange (rbcx) set is not available for return because it was discarded by the customer.

Event Description

A medwatch form was provided by the customer.The medwatch form reported that thepatient symptoms of chest tightness and/or chest pain and cough were resolved withsupplemental oxygen and epinephrine.

Manufacturer Narrative

The certification of analysis (coa) was provided to the customer.Corrected investigation: according to therapeutic apheresis: a physician's handbook, chesttightness, tachycardia, tachypnea, vomiting and coughing occur during therapeutic procedureswith a frequency of 4.8%investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide in root cause: a definitive root cause for the patient's reactions could not be determined.Basedon customer's statements about the allergic reaction and the literature review, possible causes forthe patient's reaction include, but are not limited to an allergy to replacement solution, patientsensitivity to eto, or patient's underlying disease state.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8627832
• MDR Text Key: 145643995
• Report Number: 1722028-2019-00118
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1903133230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 53