MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; HARVEST SMARTPREP2, 115V

Model Number SMP211501

Device Problems Failure to Align (2522); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2017

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.The service technician noted that the lid was hard to close completely due to the latch being out of adjustment and pressure must be applied down since it was very hard to close completely due to the latch being out of adjustment.It was also noted that the unit will run without the lid being completely latched but as soon as the lid is lifted slightly, the magnet will disengage the reed switch and the unit stops.No other functional issues were found.A simulated use testing were performed by performing three procedural cycles and it was observed that the motor spun at the correct rpm and the decantring activated properly.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the lid latch of the smartprep 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.Further evaluation of this event has determined that the device did not causeor contribute to a death or serious injury, nor is there a likely potential for death or serious injuryassociated with this event based on additional investigational information.Per terumo bct¿sinternal risk evaluation, this event is not a reportable event.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: one year of service history was reviewed for this device with no problems identified 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 mis-adjusted lid latch.Corrective action: an internal capa has been initiated to evaluate reports of lit latch failures.

Manufacturer Narrative

This report is being filed to provide additional information.

• Brand Name: HARVEST TERUMO
• Type of Device: HARVEST SMARTPREP2, 115V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7082776
• MDR Text Key: 95068616
• Report Number: 1722028-2017-00462
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/12/2018
• 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