FDA Adverse Event Malfunction Summary report: N

CADD PUMP SOLIS VIP

MDR report key: 24211592 · Received January 29, 2026

Report

Report Number
MW5183048
Event Type
Malfunction
Date Received
January 29, 2026
Report Date
January 22, 2026
Manufacturer
SMITHS MEDICAL ASD, INC./ ICU MEDICAL, INC
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
003
Health Professional
N

Narratives

Description of Event or Problem · 0

PATIENT REPORTED THAT THE SIDE WITH HOOKS, THAT THE CASSETTE WILL NOT CLICK INTO PUMP CORRECTLY. CONFIRMED CASSETTE NOT LEAKING. CONFIRMED PUMP HAS NOT BEEN DROPPED. PATIENT REPORTED THAT SHE JUST SWITCHED HER CASSETTE AND IT WORKED WITH LAST SWITCH. PATIENT SWITCHED BACK-TO-BACK UP PUMP AND INFUSING AT TIME OF CALL WITH NO ISSUES. THE SUSPECT DEVICE SERIAL NUMBER WAS NOT PROVIDED BY THE PATIENT. THE FOLLOWING DEVICE SERIAL NUMBERS ARE CURRENTLY CHECKED OUT BY THE PATIENT FOR USE: SERIAL NUMBERS: (B)(6) AND (B)(6). PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? NO. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO IS THE ACTUAL DEVICE AVAILABLE TO BE RETURNED FOR INVESTIGATION? YES. UPON RETURN. DID WE REPLACE DEVICE? YES. DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES. F YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE INFUSION LIFE-SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? ONGOING. PUMP IS BEING COURIERED. RESOLVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
268194 CADD PUMP SOLIS VIP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC./ ICU MEDICAL, INC 2120

Patients

Seq Age Sex Outcome Treatment
1 NA Female ADEMPAS.| OPSUMIT.| SODIUM SODIUM SDV.| WINREVAIR SDV.