FDA Adverse Event Injury Summary report: N

VYALEV INFUSIOIN PUMP FOR PARKINSON'S DISEASE

MDR report key: 22809629 · Received August 14, 2025

Report

Report Number
MW5174572
Event Type
Injury
Date Received
August 14, 2025
Date of Event
August 3, 2025
Report Date
August 11, 2025
Manufacturer
PHILLIPS-MEDISIZE A/S
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

I WAS EXPECTING TO REFILL MY WIFE'S VYALEV SYRINGE AT NOON ON SUNDAY (B)(6). AROUND 11:30AM IT OCCURRED TO ME THAT THE EXPECTED WARNING BEEPS HAD NOT HAPPENED. I LOOKED AT THE PUMP DISPLAY AND IT UNEXPECTEDLY SAID "DID YOU REPLACE THE SYRINGE? YES/NO" I CHOSE NO, AND THE PUMP RESTARTED, IMMEDIATELY OFFERING A 0.5 ML LOADING DOSE, WHICH I ACCEPTED. THE DISPLAY SAID THERE WERE ABOUT 4.5 HOURS LEFT TO REPLACE THE SYRINGE, SUGGESTING THAT THE PUMP HAD STOPPED AROUND 7-8AM. I DID AN EXPERIMENT AND FLIPPED OPEN THE DOOR FOR A SECOND AND CLOSED IT AND GOT THE SAME "DID YOU REPLACE..." MESSAGE. SO, IT'S POSSIBLE THAT MY WIFE, WHO HAS OCCASIONAL COGNITIVE LAPSES, MAY HAVE INADVERTENTLY OPENED THE PUMP DOOR MOMENTARILY WHEN SHE WOKE AROUND 7AM. I GAVE AN EXTRA DOSE SUNDAY AT 330PM. WHEN I REPLACED THE SYRINGE AROUND 4PM I EXPECTED THAT THE SYRINGE WOULD BE NEARLY EMPTY BUT INEXPLICABLY THE SYRINGE WAS ABOUT HALF FULL. (NO WONDER SHE WAS SO BADLY "OFF".) MY EARLIER ESTIMATE THAT THE PUMP WAS OFF FOR ABOUT 4.5 HOURS MUST HAVE BEEN VERY INCORRECT. THROUGHOUT THIS TIME MY WIFE SEEMED TO BE SLEEPING LATE, BUT AROUND 11 AM I REALIZED THAT SHE WAS PROFOUNDLY "OFF" --ESSENTIALLY "FROZEN "--AND IT TOOK MOST OF THE DAY BEFORE SHE WAS BACK TO BASELINE. IF FOR ANY REASON THE PUMP WAS STOPPED FOR HOURS, IT SHOULD HAVE MADE SOME ALARM BEEPS, JUST LIKE I BELIEVE IT WOULD DO IF THE TUBING WAS KINKED. THE FACT THAT A LOADING DOSE WAS AUTOMATICALLY PROVIDED SUGGESTS THAT THE PUMP'S SOFTWARE FIGURED OUT THAT THE PUMP HAD NOT BEEN WORKING FOR A LONG TIME, SO IT MUST HAVE THE ABILITY TO DETECT THE PASSAGE OF TIME. A VERY SIMILAR CHAIN OF EVENTS OCCURRED ON (B)(6) 2025, WHEN 4ML OF MEDICATION WAS STILL IN THE PUMP WHEN THE DISPLAY INDICATED THAT ONLY 15 MINUTES REMAINED. I THINK THIS IS A SIGNIFICANT PROBLEM WITH THE VYALEV SYSTEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1679903 VYALEV INFUSIOIN PUMP FOR PARKINSON'S DISEASE PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S

Patients

Seq Age Sex Outcome Treatment
1 75 YR Female Disability CARBIDOPA/LEVODOPA.| DULOXETINE.| LORAZEPAM.| NUPLAZID.| VYALEV.