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

Model Number 51470

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product code: fmf.Investigation: the machine was returned to terumo bct for repair and investigation.A service technician visually inspected the device and noted that the lid open detection circuit functions properly and stops the rotor when the lid is open.No other functional issues were found.Simulated use testing was done by performing three procedural cycles and it was observed that the motor spun at the correct rpm and the decant ring activated properly.The service technician observed that there were several concentric scratches on the window which indicated a possible misload of the disposable set and/or counter weights and the motor was found to be 'noisy'.The motor, scratched window and gasket were replaced, the lid latch and magnet assembly were re-adjusted.An electrical safety test hp/lc/gb (high potential/leakage current/ground bond) and a functional check out were successfully performed.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no problems identified related to the reported condition.Root cause: the root cause of this failure was a mis-adjusted lid latch.Corrective action: an internal capa has been initiated to evaluate the reports of the lid latch issues.

Event Description

The customer initially reported that a smartprep machine was not decanting properly.The device was returned for repair and evaluation.Upon evaluation of the device, the terumo bct service technician noted that the unit will run without the lid being completely latched.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

This report is being filed to provide additional information.Additional investigation: 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 based on additional investigational information.Per terumo bct¿s internal risk evaluation, this event is not a reportable event.

• Brand Name: HARVEST TERUMO
• Type of Device: SMARTPREP 2-115V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO ; 3032392246
• MDR Report Key: 7101972
• MDR Text Key: 94855641
• Report Number: 1722028-2017-00475
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 51470
• Other Device ID Number: 05020583514706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other