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

Catalog Number 10220

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Discomfort (2330); Reaction (2414)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a patient had a citrate reaction during a therapeutic plasma exchange (tpe) procedure.There was an immediate patient reaction of cold, tingly and chest discomfort.The procedure was paused, and the lines were left open to keep access.It was then discovered that the operator had switched the anticoagulant citrate dextrose solution(acda) and saline lines during set up.Once the error was recognized the symptoms subsided quickly.The cardiac physician ordered an electrocardiograph for the patient.The symptoms subsided quickly.A new tubing set and fluids were set up and the procedure was completed without further incident.The patient id, age, and weight are not available at this time.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, first time procedure patients reactions may occur in approximately 4.8% of procedures, and 1.2% of procedure patients experience reactions to citrate, based on the results of a survey of therapeutic procedures.Of these reactions, most were mild and well tolerated.According to the spectra optia¿s essentials guide, the optia system has many safety features.However, a patient reaction can occur rapidly.Therefore, it is imperative that the operator monitor the patient and the system throughout the procedure.Root cause: this disposable set was unavailable for specific root cause analysis.Based on information provided by the customer, the operator switched the acda and saline lines which resulted in the patient citrate reaction.Correction: during customer follow-up, the customer stated that they completed an internal investigation and the operator was re-trained.

Event Description

The customer declined to provide patient's identifier.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5399175
• MDR Text Key: 37135611
• Report Number: 1722028-2016-00035
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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
• Report Date: 01/29/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 10220
• Device Lot Number: 09Y3201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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): Other
• Patient Age: 46 YR
• Patient Weight: 78