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

Catalog Number 000000000000010220

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802)

Event Date 01/31/2015

Event Type  Death  

Event Description

The customer reported that the patient was undergoing a therapeutic plasma exchange (tpe) procedure and she went into cardiac arrest that lead to her expiration.Approximately 3 hours into the procedure, her heart rate decreased.The physician was notified and a code was called.The code team performed standard procedure for cardiac arrest, but was unable to revive the patient.Per the customer, the cause of death was related to the patient's disease progression and they did not allege a deficiency with the system or disposable.The customer declined to provide patient identifier, age and weight.Patient weight and gender were obtained from the run data file.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

(b)(4) manufacturing review and sterilization process review investigation: fluids used during the procedure were anticoagulant (acda), saline (b)(4) and fresh frozen plasma (ffp) was used for replacement fluid.The customer stated that the patient had ttp, suffered labored breathing, and had low oxygen saturation levels before the procedure began.Functional checkout of the machine was performed by a terumo bct service technician.All functional tests met specifications.A saline run with all alarm tests was performed without failure.All tests passed.The run data file (rdf) was analyzed for this event.The signals in the rdf indicated that the system operated as intended.According to a published article in the american journal of emergency medicine, cardiac arrest can be linked to ttp disorder.Because ttp is a disease characterized by thrombi in micro circulation throughout the body, the flow of blood to the lungs can become limited or blocked.When this occurs, it is referred to as pulmonary embolism.Fulminant pe shows a high prevalence and often degenerates into cardiopulmonary arrest.Spectra optia apheresis essentials guide provides the following cautions: "the physiological condition of patients may affect the outcomes of procedures performed on the spectra optia system." a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The patient¿s official release record and/or autopsy report were requested from the hospital¿s medical records department.Information, such as name, dob, and ssn, was stated as necessary to obtain those records.Previous attempts to obtain the patient id were unsuccessful and therefore, the official medical report(s) could not be obtained.Root cause: the definitive cause for the patient¿s death is undetermined but is not alleged to be due to the spectra optia system.Based on the nurse's description of events, dlog analysis,and machine service inspection, the likely root cause was the patient's disease state, but this could not be confirmed by the physician or with medical records.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information to align with the reported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4554905
• MDR Text Key: 5525983
• Report Number: 1722028-2015-00063
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 10W3228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 73