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

Model Number SMP211501

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

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.Two functional tests were performed with no issues found with the lid.The decant solenoid test switch was not working due to a burn on the control board and the control board was replaced.A foot was found to be missing and was replaced.The lid window and gasket were replaced due to excessive scratches.The lid latch magnet plate was replaced and the latch and magnet readjusted.The lid passed all functional tests.Ground and leakage current tests were performed with no issues found.The machine passed all functional testing with no other issues found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a procedure, the lid of a smart prep centrifuge would not stay closed.There was not a donor or patient involved at the time of the procedure, therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one year of service history was reviewed for this device with noproblems identified that were related to the reported condition.

Manufacturer Narrative

Investigation: an internal report indicates no further related issues have been reported for this device.An internal capa has been initiated to address lid latch issues.Root cause: the root cause of this failure was undetermined.The reported problem could not be duplicated.

Manufacturer Narrative

Investigation: the service technician found that the control board was damaged and not allowing the decant solenoid test switch to function and the lid window was damaged.The decant solenoid test switch is used during service to test the release solenoid and does not affect the function of the device.The physical damage reported on the lid window does not compromise the function of the device.There is no safety issue with the release solenoid or the lid window.The service technician could not duplicate the lid latch failure.The lid latch adjustment was performed per procedure.Root cause: the root cause of the lid latch failure was undetermined, the faulty control board and lid window were unrelated to the lid of a smart prep centrifuge not staying closed.

• 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: 5072129
• MDR Text Key: 26077050
• Report Number: 1722028-2015-00531
• 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,Followup,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• 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