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

Model Number 61000

Device Problems Inadequate User Interface (2958); Data Problem (3196)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported an incident of data input error in the spectra optia system.The customer entered the patient's weight in pounds, and the patient's height in centimeters.The entered and actual weight adn height of the patient is unknown at this time.Patient information are not available at this time.

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.Per the run data file, the operator entered the patient weight as (b)(6), then changed the units to lbs so the weight would be (b)(6).The system automatically converted the weight to be (b)(6).After the operator confirmed the patient data, the system generated the 'patient weight was invalid' alarm.The only option after this alarm is to end the procedure and unload the collection set.The operator ended the procedure before the patient was ever connected.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event.It was confirmed by terumo bct's service representative that no patient was connected at the time of the event and the device alarmed as designed during the data entry.An internal report shows that the machine has been in use with no further occurrences of the problem.Root cause: the root cause of the data entry error was user interface.The device failed safe with an alarm as designed.

Manufacturer Narrative

The customer stated that the operator was retrained in order toavoid further entry errors.

Event Description

No patient (donor) was connected at the time of the event.No patient (donor) information isreasonably known.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5582374
• MDR Text Key: 43714949
• Report Number: 1722028-2016-00251
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: BK140191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other