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

Model Number 51470

Device Problems Break (1069); Defective Component (2292); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: fmf.Investigation: the smartprep machine was returned to terumo bct for repair.A service technician checked out the machine and was able to duplicate the reported condition.The technician noted that the finishing washer for the lid strike screw was broken, causing the strike to be loose and the lid not able to latch properly.The finishing washer was replaced and 3 complete test cycles were performed with no issues were found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that while using the smartprep device, the balance weight inside shattered and the lid would not stay shut while the machine continued running.The operator proceeded to hold the lid latch down on the machine to complete the procedure.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: 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.Corrective action: an internal capa has been initiated to evaluate reports of lit latch failures.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.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.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause of this failure was the finishing washer.Corrective action: no corrective or preventative action is needed for this record at this time.The review indicates that the failure associated with this record did not exceed established statistical limits per our procedure.In addition, terumo bct management reviews trends at least four times per year to consider further appropriate corrective and preventative action.

• 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 80215 ; 3032392246
• MDR Report Key: 6888701
• MDR Text Key: 88239057
• Report Number: 1722028-2017-00378
• 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: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other