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

Catalog Number 10220

Device Problems Human-Device Interface Problem (2949); Inadequate User Interface (2958)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately an hour and 20 minutes into a therapeutic plasma exchange (tpe) procedure, she was trying to administer a 600 ml saline bolus for a patient's blood pressure drop to 82/40 mmhg.The rn was attempting to give the saline bolus by opening the saline roller clamps on the return line, however, she noticed that the blood started to back up into the return saline line.It was discovered that she inadvertently did not pause the procedure before opening the saline roller clamp on the return line.Blood was not observed in the saline bag.The customer was able to continue the procedure following trouble shooting with terumo bct customer service.The patient is reported in stable condition.The customer declined to provide the patient identifier.The tpe set was not available for return because it was discarded by the customer.

Manufacturer Narrative

Based on the evaluation of the procedure description, equipment, and the information provided by the customer about the patient disease state, the equipment and exchange set performed as intended.According to the mayo clinic's website, the low blood pressure experienced by the patient is a symptom of the patient's disease state, guillain-barre syndrome.Root cause: the root cause of the saline backing up into the return saline line was that the operator neglected to pause the pump before opening the saline roller clamp.With the pumps running the saline was pushed into the return saline line.The operator was corrected by the customer service consultant and was able to continue the procedure.The cause for the drop in patient blood pressure, which warranted the saline bolus administration, cannot be conclusively determined from the information provided.Patients with guillain-barre syndrome can experience blood pressure fluctuations as a side effect of this syndrome.Website address: http://www.Mayoclinic.Org/diseases-conditions/guillain-barre-syndrome/basics/definition/con-20025832.

Manufacturer Narrative

This report is being filed to provide additional information in evaluation codes and additional mfr narrative.Additional investigation: a service call was placed and a full machine checkout was performed including the functioning of the valve and pump occlusions.The machine is functioning per manufacturer's specifications.An autotest and saline run were successfully performed.

Manufacturer Narrative

Additional investigation: per the aabb therapeutic apheresis: a physician's handbook, the rate of adverse events during therapeutic apheresis is (b)(4), with most complications being minor and well tolerated.Per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 5981403
• MDR Text Key: 56108937
• Report Number: 1722028-2016-00534
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• 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,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 10220
• Device Lot Number: 08Z3224
• Other Device ID Number: 05020583102200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2016
• 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
• Patient Age: 00045 YR
• Patient Weight: 135