MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; SMARTPREP 2-115V 20/60 BW

Model Number SMP211500

Device Problems Failure to Align (2522); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product code: fmf investigation: a machine checkout was performed by a terumo bct sevice technician and was able to duplicate the reported condition.Upon visual inspection, it was noted that the lid latch magnet was found out of alignment and the magnet was unable to activate the reed switch before the lid was completely latched.The service technician replaced and adjusted the magnet plate per manufacturer's specification.Three operational runs was succesffully performed on the device.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a smartprep centrifuge lid latch was not functioning properly and the device was returned for repair and evaluation.Upon evaluation of the device, the terumobct service technician noted that the centifuge lid popped open while the rotor was still spinning.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

This report is being filed to provide additional information.Investigation: an internal report indicates no further related issues have been reported for this device.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 a mis-adjusted lid latch.

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.

• Brand Name: HARVEST TERUMO
• Type of Device: SMARTPREP 2-115V 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: 6689952
• MDR Text Key: 79758137
• Report Number: 1722028-2017-00290
• 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: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• 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