MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 000000000000061000

Device Problem Improper Flow or Infusion (2954)

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

Event Date 10/13/2014

Event Type  malfunction  

Event Description

The customer reported that at the end of a therapeutic plasma exchange (tpe) procedure,the rn noticed a discrepancy in the patient's fluid balance.At the end of the procedure, she noticed the patient's fluid balance was at 93.83% (-192 ml).Per the customer, the spectra optia machine was set for 100% fluid balance.Post hematocrit testing was done on the patient.The patient is reported in stable condition.The customer declined to provide patient identifier.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for injury has occurred.

Manufacturer Narrative

Investigation: per the customer, the nurse that set up the machine for the procedure stated that he selected custom prime.He primed the machine with 100 ml 5% albumin, then connected the patient.He set the machine for rinseback.The nurses that took over the procedure set rinseback to ¿no¿, causing the volume discrepancy.The run data file (rdf) was analyzed for this event.The rdf indicates that the operator completed set up for the run successfully.They turned custom prime on, which automatically turned rinseback off, and they entered a value of 100 ml for the return line blood warmer.There were several ¿inlet pressure too low¿ alarms and then the operator pressed the pause button and the system was shut down.The system was restarted and the procedure continued without any issues.Approximately 58 minutes into the tpe procedure, the operator went to the options screen and selected to turn rinseback on.The system reached the end of run targets and from the run targets attained screen, the operator pressed the rinseback button and then confirmed the rinseback selection.After 19 ml of fluid had been rinsedback, the operator selected to end the run without completing rinseback.The changes to the rinseback options during the run and the operator's decision to end rinseback early resulted in the fluid balance being less than 100% because the system was planning for a complete rinseback to occur in order to reach the 100% fluid balance target.The machine was checked out at the customer site.An autotest was run successfully, a fluid run was performed and alarms and occlusion pressures were verified.No issues were found with the machine.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the service history for the past year for this machine was reviewed.No additional complaints have been received for this machine regarding the reported condition.Correction: this event has been referenced to an existing software issue tracking system record.Root cause: user interface and software design.Additional information: terumo bct clinical specialist discussed the user interface error with the customer.No additional follow-up was required.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately.This supplement is being filed to modify information to align with the reported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4237391
• MDR Text Key: 5061746
• Report Number: 1722028-2014-00446
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2014

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: 000000000000061000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 11/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/20/2015; 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2011
• 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
• Patient Age: 00045 YR
• Patient Weight: 46