MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA FINAL ASSY

Model Number 61000

Device Problems Gas/Air Leak (2946); Air/Gas in Device (4062)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the terumo bct service technician performed a centrifuge pressure test and the values were found to be high, but in the aceptable range.A centrifuge pressure calibration was performed.Equipment is functioning correctly.Investigation is in process.A follow-up report will be provided.

Event Description

During a service call for "centrifuge pressure exceeded limit at therapeutic plasma exchange procedure", the terumo bct service technician noted that the sample bag was full of air and there were bubbles in the patient line.The ac line had fluid in it and the reservoir was half filled.The customer finished the procedure and the patient was disconnected.There were no consequences to the patient and no medical intervention was necessary.Patient information is not available at this time.

Manufacturer Narrative

Investigation: the customer submitted photos of the cassette, centrifuge channel, saline line, return line, ac spike, saline spike, and replacement fluid spikes.Visual inspection of the photographs did not identify any defects or mis-assemblies which could have contributed to the reported failure.The device serial number history report indicates no further related issues have been reported for this device.The device history record (dhr) was reviewed for the disposable lot that was used.There were no issues noted in the dhr that would have contributed to the event as experienced by the customer.One year of service history was reviewed for this device with no issues related to the reported condition identified.Investigation is in process.A follow up report will be provided.

Event Description

Further clarification about the event was received: the 'centrifuge pressure exceeded limit' alarm occurred during saline prime for a therapeutic plasma exchange procedure.The operator attempted to continue the procedure repeatedly, and then observed the air bubbles.The operator removed the disposable (no patient had been connected) and completed the procedure with a new disposable kit.There was not a patient connected at the time of the event, therefore, patient information is not reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: the service technician arrived on site to download the run data files and test the centrifuge pressure sensor functionality with sts software and a digital pressure gauge.The value indicated by the sensor in the sts software was found in a range of 50 mm hg of the digital gauge value.The centrifuge pressure test values were high but in the acceptable range.The centrifuge pressure sensor was re calibrated.The device was verified to be operating within specification.The technician verified the disposable set integrity and confirmed that the waste bag of the disposable was completely full of air, there were bubbles in the patient lines, ac line had fluid in it, and the reservoir was half filled.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: the specific root cause of air in the disposable set could not be determined.Based on the service technician's report, as well as the photographs submitted, it is possible there was an unidentified manufacturing defect in the disposable set which allowed the introduction of air into the ac, saline, or inlet line or there was an operator error.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA FINAL ASSY
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10454196
• MDR Text Key: 209426564
• Report Number: 1722028-2020-00404
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• Reporter Country Code: SV
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 12/14/2020; 12/16/2020; 11/18/2021
• Supplement Dates FDA Received: 12/15/2020; 01/06/2021; 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other