MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; SMARTPREP 3-115V

Model Number SMP311500

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

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

Additional product code: fmf.A machine checkout was performed by a terumo bct service technician.Upon visual inspection of the device, it was noted that the lid latch was found out of alignment and the lid cannot close without being latched.The feet, window, gasket, magnet plate, and magnet were replaced on the device.The lid latch was re-aligned per manufacturer's specification.Functional tests were successfully performed.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 terumo bct service technician noted that the centrifuge 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

Investigation: a 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 the latch failure was a misadjusted latch.

• Brand Name: HARVEST TERUMO
• Type of Device: SMARTPREP 3-115V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6450401
• MDR Text Key: 71708472
• Report Number: 1722028-2017-00103
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMP311500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• 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