FDA Adverse Event Malfunction Summary report: N

ALFAPUMP SYSTEM

MDR report key: 25131957 · Received May 9, 2026

Report

Report Number
3010817031-2026-00007
Event Type
Malfunction
Date Received
May 9, 2026
Date of Event
April 10, 2026
Report Date
May 9, 2026
Manufacturer
SEQUANA MEDICAL NV
Product Code
SDQ
PMA / PMN Number
P230044
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

I TOOK IT OUT OF THE OUTER BOX 2 DAYS PRIOR TO PROCEDURE DATE AND CHARGED IT. I WOKE IT UP, SET THE DATE/TIME, CHECKED THE PRESSURES, RAN A FEW TEST CYCLES AND THEN POWERED IT BACK DOWN. I DID NOT WAKE IT UP OR CHECK IT THE MORNING OF THE IMPLANT. AS THE PATIENT IS BEING PUT UNDER ANESTHESIA I TURNED ON THE CHARGER, PLACED IT ON THE PUMP AND WAITED. IT DIDN'T RESPOND. FINALLY IT WAS FLASHING GREEN LIKE IT WAS CHARGING BUT WOULDN'T GIVE ME A PUMP BATTERY INDICATION. I PRESSED THE MULTIFUNCTION BUTTON ON THE CHARGER TO TRY TO RESET IT. I USED FLOW TECH TO TRY TO GET A BETTER IDEA OF WHAT WAS GOING ON. IT INDICATED THE CHARGER WAS GOOD AND COMMUNICATING. THEN I WOULD GET A BATTERY INDICATION, BUT IT WAS ONE BAR[?] THEN IT WAS FULL[?] THEN IT WAS ONE BAR AGAIN. LIKE SECONDS PASS BETWEEN EACH. THE ONLY LOG I COULD DOWNLOAD WAS A C LOG. NEVER GOT ANY OTHER. WHILE TROUBLESHOOTING AT HOSPITAL I WAS ON A PHONE CALL WITH ILENIA. PATIENT WAS ALREADY UNDER ANESTHESIA AT THIS TIME. HEALTHCARE STAFF WERE WORKING ON PREPPING PATIENT AND PREPARING EQUIPMENT. THIS DID NOT HAVE AN IMPACT TO PATIENT CARE. PATIENT DID RECEIVE AN ALFAPUMP THAT DAY FROM ANOTHER SYSTEM BROUGHT AS A BACKUP (SN (B)(6)).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
359129 ALFAPUMP SYSTEM ALFAPUMP SYSTEM SDQ SEQUANA MEDICAL NV ALFAPUMP

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Hospitalization