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

Catalog Number 10220

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a patient experienced bradycardia and developed hypotension during a single needle therapeutic plasma exchange (sntpe) procedure.Approximately 47minutes into the procedure, the patient complained of tingling.Per the customer¿s adverse reaction protocol, the patient was given oral calcium and the procedure was continued.Approximately 70 minutes later, the patient¿s heart rate dropped to 65 beats per minute (bpm)and her blood pressure decreased to 44/47mmhg.The operator paused the procedure and perprotocol, the operator administered a bolus of iv fluids to the patient.The customer stated that the procedure was successfully completed.Per the customer, the patient¿s heart rate increased to 75bpm and was discharged home in stable condition.The customer declined to provide patient identifier (id).The sntpe set is not available for return because it was discarded by the customer.

Manufacturer Narrative

A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Based on the article therapeutic apheresis: a physician's handbook, an adverse events occurs during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as with apheresis (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Vasovagal reactions such as hypotension and bradycardia as experienced by the patient occur at a frequency of 0.5%.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: this report is being filed to provide corrected information and additional information.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Per the customer ,the procedure was completed without any further issues.The patient received a bolus of iv fluids and oral calcium as part of their standard operating procedure (sop) at the customer site and no medical intervention above and beyond first aid was required or ordered by the physician.The run data file (rdf) was analyzed for this event.Signals in the rdf confirmed that the spectra optia device operated as intended and no system or device malfunction was identified that may have contributed to the reported event.Per the rdf, the replacement fluid used for this event was albumin/saline and the final fluid balance was 100%.Root cause: a definitive root cause for the patient's reactions could not be determined.Possible causes for the alleged reactions include but are not limited to ac management during the procedure, patient's disease state, and/or patient sensitivity to anticoagulant.

Event Description

Review of the run data files (rdf) for the reported incident and confirmed that the reported incident occured during a dual needle therapeutic plasma exchange (tpe) procedure instead of single needle therapeutic plasma exchange (sntpe) procedure.Per customer,the operator paused the procedure and administered oral calcium and a bolus of iv fluids to the patient per standard protocol at the customer site.No medical intervention was required for this event by the physician at the customer site above and beyond first aid.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7447241
• MDR Text Key: 106064992
• Report Number: 1722028-2018-00102
• 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,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 10220
• Device Lot Number: 1708233330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• 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; Required Intervention
• Patient Age: 00047 YR
• Patient Weight: 79