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

Model Number SMP211500

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

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product code: fmf.Investigation: the machine was returned to terumo bct for repair and investigation.A service technician visually inspected the device and confirmed that the lid latch was out of adjustment.A new latch and magnet plate was installed and the lid latch was realigned.A simulated use test was performed and confirmed that the lid stayed closed through three full cycles.The machine is functioning within specification.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.Corrective action: an internal capa has been initiated to evaluate the reports of the lid latch issues.

Manufacturer Narrative

This report is being filed to provide additional information.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one year of service history was reviewed for this device with no problems identified related to the reported condition.An internal report shows that the machine has been in use with no further occurrences of the problem.Root cause: the root cause of this failure was a mis-adjusted lid latch.

• Brand Name: HARVEST TERUMO
• Type of Device: HARVEST SMP2, 115V, 20/60 BW
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6732163
• MDR Text Key: 80927177
• Report Number: 1722028-2017-00298
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMP211500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• 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