MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; SMARTPREP 2-230V

Model Number 51474

Device Problems Device Maintenance Issue (1379); Loss of Power (1475); Smoking (1585)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

Additional product code: fmf.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during surgery, a harvest smartprep centrifuge unit was used to prepare a 60 ml bone marrow aspirate concentrate (bmac).Approximately 4 minutes into centrifugation, the power to the smartprep unit ceased.The operator unplugged the unit and changed the fuse and re-powered the unit.Per the customer, the centrifuge began to operate, however, smoke was observed near the plug to the unit and the unit powered off.The patient experienced a delay of surgery and received extended anaesthesia.When the issue could not be resolved, the surgery was successfully completed without the bmac.Patient information and outcome are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in evaluation codes and additional mfr narrative.Investigation: an internal report indicates no further related issues have been reported for this device.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.The harvest device was received by terumo bct for evaluation.A bleach disinfection was performed on the machine.Upon visual inspection, it was found that the device set to 115 vac with 2 fuses in the fuse compartment burned.The fuses were replaced and the device was set to 230 vac.Upon powering up the device for testing, the centrifuge motor was found to be not running.Upon disassembly, cracks and shorts were found on the motherboard and traces to the connector were burned.It appeared that the crack stopped the centrifuge motor.When the fuse was switched out for retesting, the cracked component burned the fuse and traces on the motherboard.It was determined that the microboard was defective due to the crack and may have lead to the reported condition.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause of the lost power is undetermined.The root cause of the smoke and failure of the device to continue was an improperly installed fuse holder.

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.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: per terumo bct's internal risk evaluation documentation, a procedure for preparation of bone marrow aspirate concentrate on the harvest smartprep 2 was interrupted and the product was lost after a power failure and an attempt by the hospital staff to replace the fuse, resulting in circuit card damage, preventing recovery of the product, and requiring system repair.Anesthesia was prolonged for the attempted repair and finally the surgery was completed without the cell concentrate.The staff had an older version of the user's manual stating that users could replace the fuse, while more recent manuals states that this should be done only by a specially trained company technician.Product loss can result in a minor to moderate injury (slower or less effective tissue healing) or a delay planned surgery or treatment.

• Brand Name: HARVEST TERUMO
• Type of Device: SMARTPREP 2-230V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6149718
• MDR Text Key: 61599719
• Report Number: 1722028-2016-00637
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 51474
• Other Device ID Number: 05020583514744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• 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; Required Intervention