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

Model Number SMP2115

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the smartprep centrifuge was checked out at the customer site.Eight simulated run cycles were run without any issues.It was found that the device required an updated magnet plate and latch adjustment.Repairs were made and the unit was returned to service.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the 10th minute of a spin cycle, the lid latch of the smartprep popped open.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

Investigation: 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 undetermined.Since the adjustment of the referenced part has resolved the issue, it is likely that this part was defective or a contributing factor.An internal report shows that the machine has been in use with no further occurrences of the problem.

Manufacturer Narrative

This report is being filed to provide additional information.

• Brand Name: HARVEST TERUMO
• Type of Device: SMARTPREP 2-115V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 5988920
• MDR Text Key: 56807007
• Report Number: 1722028-2016-00535
• 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: Initial,Followup,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• 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: 11/10/2016
• 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