CADD SOLIS AMBULATORY PUMP ACCESSORY

Additional Manufacturer Narrative

D4. THE REPORTED LOT# 18676925 WAS NOT FOUND FOR THE REPORTED CATALOG# 21-2131-01. THEREFORE, EXPIRATION DATE AND H4. MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. D4. PRIMARY UDI NUMBER: THE PRIMARY DI# HAS BEEN USED AS THE LOT/SERIAL INFORMATION IS UNKNOWN. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE HAD AN OUT-OF-BOX FAILURE, WITH THE ALARMS FOR THE WIRELESS MODULE HAVING AN INTERMITTENT CONNECTION. THE DEVICE FAULT OCCURRED UPON OPENING AT THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS AN ICUMED FSE. THIS WAS NOT REPORTED TO FDA. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

D9: PRODUCT RECEIVED DATE 7/16/2024. H3: ONE DEVICE WAS RETURNED FOR REPAIR IN USED CONDITION WITH COMPLAINT THAT DEVICE ALARMS FOR WIRELESS MODULE INTERMITTENT CONNECTION. THE REPORTED COMM MODULE WAS RETURNED WITH ITS HOST PUMP AND EVALUATED. EVALUATION TEST FOUND THE FAILURE OCCURRING WHEN TESTED ON ITS HOST PUMP WITH THE POLEMOUNT CAPTURE MOUNTED BUT NOT REPEATING WHEN TESTED ON A KNOWN GOOD TEST SOLIS PUMP. NO PROBLEM FOUND WITH THE WIRELESS CONNECTIVITY FUNCTIONS OF THE COMM MODULE. DETERMINED THAT THE FAULT WAS WITH THE HOST PUMP NOT THE COMM MODULE.