MAUDE Adverse Event Report: HAEMONETICS CORPORATION HAEMONETICS SMARTSUCTION TECHNOLOGY; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number	HAR-A-1000
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Malfunction of the cell saver that occurred during this case.It's an open aneurysm.The cell saver suction wasn't working properly, the vacuum line and also the aspiration line was switched during the case so i don't know if the previous lines that were hooked up malfunctioned in some way.

• Brand Name: HAEMONETICS SMARTSUCTION TECHNOLOGY
• Common Device Name: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer st; boston MA 02110
• MDR Report Key: 15592614
• Report Number: 15592614
• Device Sequence Number: 11344981
• Product Code: BTA
• UDI-Device Identifier: 10812747017336
• UDI-Public: (01)10812747017336(17)240223(10)0221053
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022
• Report Date (Section F): 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HAR-A-1000
• Device Lot Number: 0221053
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/20/2022