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

Catalog Number 10220

Device Problems Occlusion Within Device (1423); Use of Device Problem (1670)

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

Event Date 05/13/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow-up report will be reported.

Event Description

The customer reported that approximately 10 minutes before the end of a therapeutic plasma exchange (tpe) procedure, air was noted in the return line in the blood warmer tubing.The procedure was ended immediately and the patient was disconnected.Per customer, no air was returned to the patient and no alarms occurred during the procedure.The patient is reported in stable condition.The customer declined to provide the lot number information and patient id, age and gender.The tpe 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.Investigation: the optia machine is equipped with a return line air detector that detects air in the return line.If the volume of air detected exceeds what is safe for the patient to have in circulation, the return line air detector (rlad) alarms will be generated to alert the operator to perform an air removal to remove the air from the line.For this reported event, terumo bct was unable to determine if the operator had received any alarms as the customer declined to provide additional procedural details.Root cause: a definitive root cause for air in the blood warmer tubing could not be determined.Possible causes include but are not limited to:- operator failed to check for air in return line following low level too late alarm resulting in air in the return line and subsequently, in the blood warmer tubing.- operator failed to notice empty saline bag at the start of the return line air recovery resulting in air in the return line.- operator failed to open return saline line for the return line air recovery resulting in air in return line.- the luer connecting the return line to the blood warmer tubing was not tight and the position of the luer connection was 20 inches higher than the return line resulting in air in the set.

Event Description

After multiple attempts for follow-up, the customer did not provide additional procedural details, including the specific incident date.

Manufacturer Narrative

This report is being filed to provide additional information.Additional information; a terumo bct service technician performed preventive maintenance on this machine on a later date, 8/8/2018 and no issues were found.The system performed as intended.

• 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: 7606894
• MDR Text Key: 112173153
• Report Number: 1722028-2018-00179
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• 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: 06/15/2018

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/24/2018
• Supplement Dates FDA Received: 08/03/2018; 09/21/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 25