MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; SMARTPREP 2-115V

Model Number SMP211501

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

Additional product code: fmf investigation: the machine was checked out by a terumo bct service technician.Technician powered the machine on and it ran normally.The lid latch was realigned and the magnet plate was replaced.The machine passed a lid latch test run.During testing, the machine intermittently stopped by itself.The display board was found to have a bad stop switch.The display board was replaced and all functional tests were repeated successfully.The feet were replaced and the machine cleaned.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a smartprep centrifuge was not functioning properly and a service call was initiated to evaluate the device.Upon evaluation of the device, the terumo bct service technician noted that the centrifuge lid popped open when 'stop' was pressed on the device and the rotor was still spinning.There was not a donor or patient involved at the time of the incident, therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

Investigation: the display board was received for investigation.Visual inspection revealed no anomalies.An inspection of the stop switch found s3 to intermittently disconnect when pressed.The technician was able to duplicate the issue that could lead to the reported problem.One year of service history was reviewed for this device with no problems identified that were related to the reported condition.An internal report indicates no further related issues have been reported for this device.Root cause: the root cause of this failure was a faulty display board and misadjusted lid latch.Corrective and preventative action: an internal capa has been initiated to address latch mechanism issues.

• Brand Name: HARVEST TERUMO
• Type of Device: SMARTPREP 2-115V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5079779
• MDR Text Key: 26291464
• Report Number: 1722028-2015-00550
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMP211501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other