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

Catalog Number 10220

Device Problems Air Leak (1008); Use of Device Problem (1670); Incomplete or Inadequate Connection (4037)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a red blood cell exchange (rbcx) procedure, the nurse noticed air bubbles in the blood warmer tubing that was connected to the return line and air was seen moving towards the patient.The nurse paused the procedure, disconnected the blood warmer tubing and primed another blood warmer tubing set and continued the procedure.The procedure was successfully completed and the patient is reported in stable condition.Per the customer, no issues were noted with the patient post-procedure and no medical intervention was required for this event.The customer declined to provide patient identifier (id) and weight.The red blood cell exchange (rbcx) set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a custom prime was performed for this patient using albumin.No rlad alarms were reported by the customer to have occurred.The customer reported that the air was seen approximately part way through the procedure.During a custom prime, air can be drawn into the system if the custom prime fluid container is completely emptied prior to the end of custom prime or if cold albumin is used.This could cause the fluid to continue to outgas in the blood warmer tubing.Additionally, if cold replacement fluid is used, continuous outgassing could also occur.Root cause: based on the information available, if there was air in the return line, it cannot be ruled out that air in the return line could have been due to the following root causes at the beginning of the procedure.- loose luer connection with blood warmer mounted above 20 inches- air introduced during customer priming using cold albumin which continues to outgas in the blood warmer tubing- continuous outgassing of blood because the replacement fluids were cold.

Manufacturer Narrative

This report is being filed to provide additional information.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.

• 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: 7335950
• MDR Text Key: 102850438
• Report Number: 1722028-2018-00064
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• 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: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 10220
• Device Lot Number: 1712203230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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
• Patient Age: 00007 YR