Description of Event or Problem · 0
THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: THE CUSTOMER HAS REQUESTED A FULL INVESTIGATION FOLLOWING A REPORT FROM A USER IN PICU THAT THREE INAPPROPRIATE BOLUSES WERE DELIVERED DURING A FENTANYL INFUSION USING AN AGILIA SP MC WIFI DEVICE ON (B)(6) 2025. THE DEVICE HAD BEEN PROGRAMMED USING THE 2-5 KG PICU PROFILE WITHIN THE NHS GGC PICU SP V.12.00 DATASET, WITH THE INFUSION PROGRAMMED AS DRUG X. PATIENT HAD A RESPIRATORY ARREST SHORTLY AFTER THE THIRD BOLUS. AN INTERNAL INVESTIGATION HAS BEEN CONDUCTED, HOWEVER, DUE TO THE LEVEL OF HARM TO THE PATIENT, THE CUSTOMER CONSIDERED IT PRUDENT THAT THIS MATTER IS FURTHER INVESTIGATED BY FRESENIUS-KABI. SUPPORTING DOCUMENTATION HAS BEEN PROVIDED, INCLUDING THE INCIDENT EVENT LOG AND INFUSION RECORD, TEST EVENT LOG AND INFUSION RECORD (FROM THE INTERNAL INVESTIGATION), AS WELL AS THE CURRENT DATA SET REPORT. PLEASE NOTE THE INFUSION RECORD IS 1 HOUR OUT OF SYNC WITH THE EVENT LOG. THE CUSTOMER ASSUMED THIS MAY BE DUE TO DAY LIGHT SAVING TIME CHANGEOVER. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.