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

Model Number SMP211500

Device Problems Device Slipped (1584); Failure to Align (2522); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2017

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 was able to duplicate the reported condition.The service technician noticed that the lid magnet was not properly aligned which caused the lid to open and the led light turns off before the lid latches giving a false indication of being closed.It was also noted that the machine runs with the lid not fully latched, however, as soon as the machine completely stops, the lid pops opens and the led light turns on.The magnet plate and window/gaskets assembly were replaced.The latch and magnet adjustment were performed per manufacturer's specification.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a smartprep centrifuge lid latch was not locking properly and was unable to start a procedure.The device was returned for repair and evaluation.Upon evaluation of the device, the terumo bct 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: 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.One year of service history was reviewed for this device with no problems identified related to the reported condition.The device serial number history report indicates no further related issues have been reported for this device.Root cause: the root cause of this failure was a mis-adjusted lid latch.Corrective action: an internal capa has been initiated to evaluate reports of lit latch failures.

Manufacturer Narrative

This report is being filed to provide additional information.

• 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: 6972816
• MDR Text Key: 90952846
• Report Number: 1722028-2017-00411
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• 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: 01/03/2018
• 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