MAUDE Adverse Event Report: LIVANOVA USA, INC. BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM; APPARATUS, AUTOTRANSFUSION

Model Number 007320000

Device Problems Device Tipped Over (2589); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement.Through follow-up communication with the customer, livanova was able to gather additional information about the event.The customer stated that the caster wheels fell off the bottom of the unit as the perfusionist pushed the device over a metal plate in the hallway, which caused the front end to lift off and the casters to drop down.When the weight of the machine was placed back onto the wheels, the casters bent at an angle and when the device was pushed forward, the wheels came completely off and the device tipped over.The iv pole hit the perfusionist in the head and a visit to the er was required.However, the customer reported that the injury was not serious.The device was inspected by the facility and it was discovered that the set screw that holds the wheel on had worked its way loose over time and fell out.There was no other damage to the unit, and the set screws have been replaced.A livanova field service representative was dispatched to the facility to investigate.The rear casters were inspected to confirm that they were secure and no issues were noted.Functional testing was performed without issue and the device was returned to service.Review of the complaint history did not point out any similar issue even on machine after prolonged use over years.This issue was determined to be caused by unusual wear of the device.However, it was an isolated case.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that the front wheels came off of a brat 2 autologous blood salvage system during transport to the operating room and the device fell forward.The iv pole connected to the device reportedly hit the perfusionist in the head.There was no patient involvement.

• Brand Name: BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7684705
• MDR Text Key: 113868450
• Report Number: 1718850-2018-00011
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 007320000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other