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

Catalog Number 12220

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: prescribed fluid balance was 100%.Per the customer, the saline roller clamps were on the correct lines and properly closed.The procedural cautions section of the spectra optia apheresis system essentials guide states that if the roller clamp on the saline line is left completely open when the patient is connected, the patient will be quickly infused with a large volume of saline.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 during a therapeutic plasma exchange (tpe) procedure on a spectra optia device it was noticed that the saline roller clamp was open and the fistula access was closed.No blood was coming into the centrifuge, only saline.The return line was open and the patient received 200ml of albumin as replacement fluid before the operator noticed the saline roller clamp was open.The doctor at the customer site stated they were ok with that.The remove bag received the saline that was sent to the centrifuge from the open roller clamp.The customer reported that the device showed an 'interface is taking too long to establish' alarm.The operator closed the inlet saline roller clamp and continued the tpe.The procedure was completed.Per the customer, "the patient did great and went home." the customer declined to provide patient information and any further procedural details for this event.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Correction: the terumo bct provided the customer with information via email emphasizing the importance of following the screen prompts to close the inlet saline roller clamp at the time of the initial call.The customer understood and acknowledged the receipt of this information.Root cause: based on the customer statements and clinical findings, the root cause was related to the operator's failure to follow the screen prompt to close the inlet saline roller clamp at the end of prime divert.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11307622
• MDR Text Key: 232544016
• Report Number: 1722028-2021-00062
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2005223230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other