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

Catalog Number 10220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Tachycardia (2095); Increased Respiratory Rate (2486)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: terumo bct customer support recommended to perform a saline rinse prior to the procedure.As per tbct's certificate of analysis (coa), the amount of eto in the disposable set is validated tobe < 6 mg.Journals recommended to the customer in relation to ethylene oxide (eto) sensitization are: transfusion.1987 jan-feb;27(1):90- sensitization of repeat plasmapheresis donors to ethylene oxide gas.Dolovich j, sagona m, pearson f, buccholz d, hiner e, marshall c.2.N engl j med.1986 nov 6;315(19):1192- allergic reactions in healthy plateletpheresis donors caused by sensitization to ethylene oxide gas.Leitman sf, boltansky h, alter hj, pearson fc, kaliner ma.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 at the beginning of the red blood cell exchange (rbcx) procedure on a spectra optia device, a sickle cell patient experienced an allergic reaction.The customer stated that after processing about 100mls of blood, the patient complained of chest tightness, tachycardia, tachypnea with vomiting and coughing.The procedure was paused immediately and per physician's orders, the patient was administered benadryl 25 mgs iv and 20mgs pepcid iv intravenously to manage the symptoms.Per the customer, the patient started to feel better following the administration of the medications.The patient's chest tightness started to lower from the pain scale of 8 points down to 4-5 points.Per the customer, as soon as rinse back was started, the patient started to have reaction symptoms again.The procedure was terminated immediately and the patient was shifted to the emergency room (er).Per the customer, the patient has had similar procedures for several years without any issues.As per last available information the patient is reported to be 'discharged'.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.

Manufacturer Narrative

This report is being filed to provide root cause: a definitive root cause for the patient's reaction could not be determined.Basedon information provided, possible causes of the allergic reaction include, but are not limited to anallergy to replacement solution and/or patient sensitivity to eto (patient has been sensitized withthe residual eto in the sets over time), patient's sensitivity to anticoagulant and/or patient'sunderlying disease state.

Event Description

The customer reported to tbct that they administered benadryl 25 mgs iv and 20 mgs pepcidiv intravenously to manage the symptoms, however, the recieved medwatch indicatesbenadryl 50 mgs iv and 40 mgs pepcid.

Manufacturer Narrative

H.10.Investigation: a medwatch was filied by the customer for this event (mw5086593).According to therapeutic apheresis: a physician's handbook, chest tightness, tachycardia,tachypnea, vomiting and coughing occur during therapeutic procedures with a frequency of4.8%.Certification of analysis (coa) was provided to the customer by terumobct.Investigation is in process, a follow-up report will be provided.- attachment: [mw5086593 (220348278).Pdf].

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8627893
• MDR Text Key: 145751876
• Report Number: 1722028-2019-00119
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K181049
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 10220
• Device Lot Number: 1901173130
• 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: 66