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

Catalog Number 10220

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Discomfort (2330)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: the immunosorba column is reusable and was used for the 15th time.Per the physician, the reaction was from the column or from the ethylene oxide (eto) sterilization of the optia set.This was the 6th optia run.There was no issue with the patient on previous runs, which alsoused optia sets from the same lot and the same columns.The customer is testing the patient's blood for eto antibodies.(b)(6) deinvestigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 43 minutes into an exchange procedure with a secondary plasma device (spd) involving a combination of the medicap adasorb device and the immunosorba protein a column, the patient complained of serious discomfort and itching on her skin.Her skin was then covered by lumps and she complained of feeling hot and uncomfortable.The procedure was immediately paused and fenistil via iv was administered to minimize the allergic reaction.The patient gradually felt better.Per the doctor's request, the procedure was continued slowly (10ml/min inlet).The speed was increased to 50 ml/min inlet as the patient was feeling better, but after another 10 minutes, the patient complained of difficulty breathing.The procedure was immediately terminated and rinse back was not performed.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable set is not available for return for evaluation because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer indicated that for these procedures the nacl that is used to rinse any remaining eto from the optia exchange set is also used to pre-fill the plasma line leading to the secondary processing device.A review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file was analyzed for this event.Root cause: review of the run data file for this procedure indicated no system-related cause for the reported allergic reaction.In rare cases, the ethylene oxide (eto) that is used to sterilize spectra optia disposable sets has been known to cause allergic reactions in patients with an eto sensitivity.The incidence of eto reactions in secondary plasma device (spd) procedures may be slightly higher, as a majority of the saline used to prime the set is delivered back to the patient at the start of the run, particularly if prime divert of the secondary device is not performed.However, experience in these situations has shown that the reaction to the eto generally occurs shortly after the optia device begins the initial return of fluid in the set back to the patient/don in addition, the reported symptoms typically include a drop in blood pressure and the patient becomes flushed.In the case of this procedure, the timing of the allergic reaction (43 minutes into the procedure) and the reported symptoms do not align with what is expected of a typical reaction to eto.Consequently, residual eto in the disposable set is not suspected as the root cause of the reaction.In the event possible eto reaction is a concern, the optia system has an option that allows the fluid pathway of the disposable set to be rinsed with saline after the system has been primed to minimize the amount of residual eto returned to the patient.Other sources of allergic reaction during spd procedures may include, but are not limited to: any additional disposable tubing/components used to connect to the secondary device and the device itself (i.E.The column).Furthermore, it is possible for a patient to develop an allergy to something contained within the column after repeated use of a reusable column.The spectra optia system has many safety features.A donor and/or patient reaction can occur rapidly, however.It is imperative that the operator continuously monitor the spectra optia system and the donor and/or patient.

Event Description

The patient's weight and gender were obtained from the run data file.

Manufacturer Narrative

Additional information: per the therapeutic apheresis handbook, reactions may occur in as many as 7.8% of plasma exchange procedures.Allergic reactions are typically associated with replacement regimens that include blood components but they can also be caused by sterilization of disposable tubing with ethylene oxide.Symptoms include hives, wheezing, and facial swelling.The guide recommends that a specific protocol for treatment of anaphylaxis should be prepared in advance under direction of the apheresis physician.Correction: terumo bct contacted the customer repeatedly in an attempt to gather information concerning any ige antibody testing that would indicate an allergic reaction to eto.The customer indicated that no testing for ige antibodies had been conducted.Additionally, the patient had undergone 20 additional procedures on optia since this reported one with no problems.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: kristen cohen ; 10810 w collins ave; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 5220621
• MDR Text Key: 31030123
• Report Number: 1722028-2015-00614
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: BK140191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2015

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: 06/01/2017
• Device Catalogue Number: 10220
• Device Lot Number: 06Y3123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/09/2016; 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2015
• 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): Required Intervention
• Patient Weight: 72