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 Dyspnea (1816); Urticaria (2278); Sweating (2444)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Additional patient code: (b)(4).Swelling investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that the patient had a 'severe' reaction during a therapeutic plasma exchange (tpe) procedure.During the procedure,the patient complained of feeling diaphoretic, swelling, shortness of breath (sob) and developed hives.The rn stopped the procedure without rinse back.Per the rn, the patient was given 50mg benadryl via iv,hydrocortisone via iv, oxygen (o2) and the patient was intubated.The patient is reported in stable' condition.The patient identifier is not available at this time.The therapeutic plasma exchange (tpe) set is not available for return because it was discarded by the customer.

Manufacturer Narrative

The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.A terumo bct technician performed a full machine checkout at the customer site.The machine is functioning per manufacturer's specification.The technician also verified that the aim system pre and post startup tests successfully passed.An auto test and saline run were also successfully performed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer did not respond to attempts to obtain information for the investigation such as procedural details, patient information and lot information.

Manufacturer Narrative

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.The run data file (rdf) was analyzed for this event.The signals in the rdf indicated that the spectra optia system operated as intended.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 and/or patient sensitivity to eto.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w.collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7040868
• MDR Text Key: 92318298
• Report Number: 1722028-2017-00446
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2017

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 02/13/2018
• Supplement Dates FDA Received: 12/12/2017; 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 00025 YR
• Patient Weight: 95