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

Catalog Number 000000000000010220

Device Problem Temperature Problem (3022)

Patient Problems Tachycardia (2095); Alteration In Body Temperature (2682)

Event Date 05/16/2015

Event Type  Injury  

Event Description

The customer reported that during rinseback after a therapeutic plasma exchange (tpe)procedure, the patient experienced a raised temperature and raised heart rate.The rapidresponse team was called and the patient was given clonadine 0.3mgs, tylenol 650 mgs andlasix 100mg in response to the event.The patient is in stable condition.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the customer, fluids hanging were anti-coagulant acda and normal saline.Replacement fluid used was 5% albumin.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

(b)(4).Investigation: the disposable set was unavailable for return and investigation.The run data file (rdf) was analyzed for this event.Based on an evaluation by the physician, the symptoms were due to the patient's physiology.A service call was placed for the machine.Upon inspection, the machine alerted that there was a dirty fluid detector which was then cleaned.There was also an alarm for a malfunctioning door latch.The machine performed as designed and these alarms would not have contributed to the patient¿s reaction which occurred after the procedure.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The spectra 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.The physician suspects the patient had an allergic reaction or an episode of pulmonary edema.Root cause: a definitive root cause for the patient reaction could not be determined.Based on the rdf analysis and the machine service call, the system performed as designed.A possible cause is but not limited to the patients pre-existing condition.

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 in 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: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4840299
• MDR Text Key: 5943265
• Report Number: 1722028-2015-00214
• 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,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 04Y3322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 88