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

Catalog Number 10220

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Loss of consciousness (2418); Decreased Respiratory Rate (2485)

Event Date 02/16/2014

Event Type  Injury  

Event Description

The customer reported that a patient went into cardiac arrest during a therapeutic plasmaexchange (tpe) procedure.Ninety minutes into the procedure, the patient's respiratory and heartrate declined and he became unresponsive.A medical code was called.The patient remained inicu after the incident.Per the customer, the patient was then stable enough to be transferred to another hospital.Customer declined to provide patient identifier.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to a code being called for the patient.

Manufacturer Narrative

Investigation: a service call was placed and the technician performed an autotest and saline procedure with no unexpected alarms.Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The run data file (rdf) was analyzed for this event.Root cause: the disposable set was unavailable for specific root cause analysis.A definitive root cause could not be determined.Signals in the rdf showed the machine operated as intended.Possible causes for the patient reaction include but are not limited to the patient's disease state and/or reaction to fresh frozen plasma.The spectra optia apheresis system essentials guide provides the following warning for solutions and medicinal fluids: "when using biologically-derived replacement fluids, closely monitor the patient for reactions.".

Event Description

The customer stated they were not able to release the patient identifier, medical history or the reason for the tpe procedure.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury on the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3678982
• MDR Text Key: 4291910
• Report Number: 1722028-2014-00086
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK870022
• 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,Followup
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• 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
• Date Manufacturer Received: 02/03/2016
• 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: 00082 YR
• Patient Weight: 129