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

Catalog Number 12220

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Cardiomyopathy (1764)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer,the patient received two tpe procedures on the (b)(6) 2019 in the icu using albumin 4% as replacement fluid without any adverse event.Per the rn, multiple spectra optia devices and disposable sets were used over the course of the patient's treatments.Per attending physician ,the cardiac arrest was "absolutely not" related to the tpe procedures but rather the underlying diagnosis and comorbidities including cardiac myopathy.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a myositis patient having signal recognition particle (srp)antibodies causing severe necrotising myopathy experienced a 'cardiac arrest' in icu two days after undergoing the therapeutic plasma exchange (tpe) procedure on spectra optia in intensive care unit (icu).Per the rn,the patient was 'stabilized' as a result of the resuscitation efforts taken following the cardiac arrest and 'stayed' in the icu.Per the customer on (b)(6) 2019, the tpe procedure was reinstituted on the patient and (b)(6) 2019, the patient underwent the last procedure without any adverse event.There were no adverse events noted (e.G transfusion reaction, citrate toxicity etc) during any of the procedures as per the nursing staff.Per last available information the patient stayed in icu.Patient identifier (id), gender and weight information are not available at this time.The tpe set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: based on the information provided by the attending physician, the root cause ofthe patient's cardiac arrest was due to patient physiology.

Manufacturer Narrative

This report is being filed to provide updated information in g.1 and g.2.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8833151
• MDR Text Key: 152495473
• Report Number: 1722028-2019-00201
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• 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: 12220
• Device Lot Number: 1901233230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00062 YR
• Patient Weight: 45