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

Model Number 61000

Device Problems Use of Device Problem (1670); Inadequate User Interface (2958)

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

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they inadvertently selected a therapeutic plasma exchange (tpe) procedure instead of a red blood cell (rbcx) exchange procedure from the spectra optia display screen.No medical intervention was required for this event.The patient is reported instable condition and the customer stated that the patient is 'okay'.Patient information is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Updated investigation: the customer did not provide the serial number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All equipment serial number must meet acceptance criteria before release.

Event Description

The customer did not respond to multiple attempts to obtain additional information for the investigation such as patient information and device serial number.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during follow-up with the customer, the medical director at the customer site reported that they could not remember the exact date of the procedure, therefore no patient information could be provided other than the presenting diagnosis, which was sickle cell disease.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one year of service history was reviewed for this device with no similar issues to the reported condition identified.Root cause: user interface issue.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6526031
• MDR Text Key: 74045797
• Report Number: 1722028-2017-00155
• 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,Followup
• Report Date: 04/27/2017

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
• Other Device ID Number: 05020583610002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 08/11/2017; 09/01/2017; 09/13/2017
• Supplement Dates FDA Received: 08/11/2017; 09/05/2017; 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other