MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; SMP2-115V HARVEST 20/60

Model Number SMP2115

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product code: fmf investigation: the smartprep device was returned to terumo bct for repair and evaluation.The service technician was able to duplicate the reported condition.A simulated use test was performed by performing four full procedural cycles with no issues noted.At the start of the fifth cycle, the service technician noticed that the decant solenoids activated the lid solenoid causing the lid to open.However, it did not open enough to stop the smartprep device from running.After slightly lifting the lid, the reed switch detected the open lid and shut down the unit.The main control board was replaced to address the issue.The smartprep display board, display panel, ribbon cable, and membrane switch were replaced for compatibility with the new control board.The vibration isolation, latch plunger springs, feet, window, gasket and magnet plate were proactive replacements.The latch was adjusted to meet the 25lbs.Latching requirement.All functional tests were successfully performed with no issues after the repair.An internal report shows that the machine has been in use with no further occurrences of the problem.One year of service history was reviewed for this device with no problems identified related to the reported condition.Corrective action: an internal capa has been initiated to evaluate reports of the iv poled ropping down suddenly.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after the first centrifuge spin, the smartprep device stops the centrifuge and unlocks the lid latch.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 and corrected 'corrective action statement.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.Root cause: the root cause of this failure was the main control board.

• Brand Name: HARVEST TERUMO
• Type of Device: SMP2-115V HARVEST 20/60
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6978001
• MDR Text Key: 91074154
• Report Number: 1722028-2017-00417
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103340
• 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
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMP2115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• 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