ALFAPUMP SYSTEM
Report
- Report Number
- 3010817031-2026-00005
- Event Type
- Malfunction
- Date Received
- March 12, 2026
- Date of Event
- February 12, 2026
- Report Date
- March 12, 2026
- Manufacturer
- SEQUANA MEDICAL NV
- Product Code
- SDQ
- PMA / PMN Number
- P230044
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
INVESTIGATION INITIATED.
PRIOR TO THE IMPLANT PUMP SN (B)(6) WAS POWERED ON BY MY COLLEAGUE (B)(6). IT REMAINED IN STERILE PACKAGING AND INSIDE PACKING BOX, COMMUNICATION WITH THE PUMP WAS DONE VIA RADIO WAVES USING THE WIRELESS CHARGER. IN ATTEMPTING TO PERFORM TEST CYCLES TYLER HAD A RED "X" ON THE SCREEN AND "MOTOR COMM" IN RED SCRIPT. THIS IS ADDRESSED IN OUR WORK INSTRUCTIONS, AND THE OPTIONS WERE TO CHARGE THE SYSTEM OR USE THE BACKUP SYSTEM. AS INTERROGATION SOFTWARE WAS DISPLAYING A HEALTHY VOLTAGE ON THE BATTERY, WE DECIDED TO USE THE BACKUP SYSTEM (SN (B)(6)) AFTER A PHONE CALL WITH OUR TECHNICAL SUPPORT STAFF. REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT: PATIENT WAS ENTERING THE ROOM AT THE TIME OF PUMP SN (B)(6) POWER ON. TWO COMPLETE SYSTEMS ARE BROUGHT TO EACH IMPLANT. TYLER AND I SWITCHED OUR ATTENTION TO THE BACKUP SYSTEM AND PROVIDED THIS EQUIPMENT TO THE IMPLANTING STAFF FOR THE PATIENT. I DO NOT BELIEVE ANY DELAY OF CARE RESULTED FOR THIS PATIENT AS WE WERE ABLE TO ARRANGE OUR SUPPLIES AND PREPARE THE PUMP WHILE THE IR STAFF WERE DOING OTHER ACTIVITIES TO PREPARE THE PATIENT FOR THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639681 | ALFAPUMP SYSTEM | ALFAPUMP | SDQ | SEQUANA MEDICAL NV | 01473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |