FDA Adverse Event Malfunction Summary report: N

PSI-TEC III ASPIRATOR

MDR report key: 21936576 · Received April 30, 2025

Report

Report Number: MW5169674
Event Type: Malfunction
Date Received: April 30, 2025
Date of Event: April 22, 2025
Report Date: April 24, 2025
Manufacturer: BYRON MEDICAL / MENTOR TEXAS L.P.
Product Code: MUU
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: TX, US
Reporter Occupation: RISK MANAGER
Health Professional: Yes

Narratives

Description of Event or Problem · 0

S: THE NEW PSI-TEC III ASPIRATOR LIPOSUCTION MACHINE MALFUNCTIONED DURING A CASE. NO SAFETY/ PATIENT HARM. CASE WAS ABORTED. B: PATIENT WAS SCHEDULED FOR A REVISION OF BILATERAL BREASTS WITH FAT GRAFTING (WITH USE OF LIPOSUCTION MACHINE) ON 4/22 10:00AM. A: THE NEW LIPOSUCTION MACHINE MALFUNCTIONED DURING THE CASE. THE MACHINES NON-DISPOSABLE SUCTION CANISTER BEGAN NOT FUNCTIONING. THERE WAS NO SUCTION PRESSURE. THE BAG OF STERILE WATER UTILIZED IN CONJUNCTION WITH THE MACHINES PROPER SEQUENCE BEGAN FLOWING INTO THE MACHINE INSTEAD OF SUCTION CONTAINER. THE WATER IN THE MACHINES HARDWARE CAUSED THE MACHINE TO SHUT DOWN AND NOT POWER BACK ON. SINCE THE CASE WAS FOR LIPOSUCTION FOR FAT GRAFTING, THE CASE HAD TO BE ABORTED DUE TO WE HAVE ONLY ONE LIPOSUCTION MACHINE. DR (B)(6) PERFORMS ALL OF HIS LIPOSUCTION NEEDS CASES HERE AT THAM. HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) WAS IMMEDIATELY NOTIFIED AND SERVICE TICKET PLACED. STERILE WATER WAS FOUND IN THE MACHINE. THE VALVE TO THE SUCTION CANISTER WAS DISCOVERED TO BE BROKEN WHICH CAUSED THE STERILE WATER TO PUSH INTO THE MACHINE. OPERATING ROOM SCHEDULERS ARE AWARE THE LIPOSUCTION IS OUT OF SERVICE. R: HTM HAS ORDERED THE REPLACEMENT VALVE. THE MACHINE HAS DRIED OUT COMPLETELY AND PASSED ALL BIOMED TESTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
191904	PSI-TEC III ASPIRATOR	SYSTEM, SUCTION, LIPOPLASTY	MUU	BYRON MEDICAL / MENTOR TEXAS L.P.

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR	Female