INJECTOMAT MC AGILIA D
Report
- Report Number
- 3000240707-2025-00212
- Event Type
- Malfunction
- Date Received
- March 27, 2025
- Date of Event
- March 7, 2025
- Report Date
- May 6, 2025
- Manufacturer
- FRESENIUS VIAL S.A.S
- Product Code
- FRN
- PMA / PMN Number
- K121613
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
N/A.
THE FOLLOWING HAS BEEN REPORTED: DRUG LIB IN USE. ACCORDING TO A TELEPHONE CALL FROM THE MEDICAL TECHNOLOGY DEPARTMENT, PATIENT ENDANGERMENT DUE TO OVERDOSING/FAULTY "SUPPLY" OF THE DEVICE. ON (B)(6), NO ONE WAS THERE TO PROVIDE FURTHER INFORMATION. ON 11.3. ONLY INFORMATION FROM A THIRD PARTY. DEVICE HAD STARTED AUTOMATICALLY WITH POTASSIUM CHLORIDE. DOCTOR PRESENT WAS ABLE TO STOP THIS. IT WAS NOT POSSIBLE TO SAY EXACTLY ON WHICH DAY THIS TOOK PLACE. ADDITIONAL INFORMATION COMPLAINT MANAGEMENT: WE ARE GOING TO GATHER MORE INFORMATION ABOUT THE EXACT EVENT DATE. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EVENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED WITH THE REPORTED ISSUE WAS FOUND. THE DEVICE LOG WAS REVIEWED AND DID NOT SHOW ANY MALFUNCTION CORRESPONDING TO THE COMPLAINT DESCRIPTION. FROM (B)(6) 2025, AT 12:33:25 TO (B)(6) 2025, AT 03:45:42, NO DRUG CHANGE WAS SELECTED; THE INFUSION REMAINED ON DRUG X IN "ML/H" MODE, WITH FLOWRATES OF 5, 7, OR 8 ML/H. ON (B)(6) 2025, AT 03:45:43, FOLLOWING A PAUSE OF 22648 SECONDS (APPROXIMATELY 6 HOURS AND 17 MINUTES), THE DRUG "PDK - STANDARDLSG" WAS SELECTED, AND AN INFUSION WAS INITIATED AT 12 ML/H. HOWEVER, THIS INFUSION WAS STOPPED IMMEDIATELY AFTER ONLY 0.08 ML HAD BEEN DELIVERED. THEN, AT 03:46:07, AFTER A POWER CYCLE (DEVICE OFF/ON), DRUG X IN "ML/H" MODE WAS SELECTED AGAIN. THE REPORTED DEVICE WAS RECEIVED IN BRÉZINS FOR INVESTIGATION. ACCORDING TO OUR INVESTIGATION, TRACES OF IMPACT WERE FOUND ON THE HOUSING DURING THE VISUAL INSPECTION. REPRODUCTION TESTS BASED ON THE COMPLAINT DESCRIPTION WERE PERFORMED ON THE DEVICE. THE DEVICE WAS SWITCHED ON USING THE MAINS SUPPLY. A BRAUN PERFUSOR 50CC SYRINGE WAS INSTALLED AND AUTOMATICALLY DETECTED. DRUG X WAS SELECTED IN THE "ML/H" MODE. THE FLOWRATE WAS SET TO 5.0 ML/H, AND THE PAUSE FUNCTION WAS ACTIVATED FOR 5 MINUTES. THE SYRINGE CLAMP WAS OPENED, THE BRAUN PERFUSOR 50CC SYRINGE WAS INSTALLED AGAIN, AND AUTOMATICALLY SELECTED. THE DEVICE DISPLAYED "DRUG X" (ML/H) ONCE MORE, NOT THE PDK STANDARD. THE SAME INFUSION DETAILS REMAINED DISPLAYED ON THE DEVICE. THIS TEST SEQUENCE WAS REPEATED FIVE TIMES, ALWAYS WITH THE SAME RESULT: DRUG X (ML/H) REMAINED PRESELECTED BUT COULD BE MODIFIED MANUALLY (NO AUTOMATIC DRUG SELECTION OCCURRED). THE INTERNAL CHECK REVEALED THAT THE SCREW MOVED FREELY INSIDE THE DEVICE BUT WAS NOT RELATED TO THE COMPLAINT DESCRIPTION. AS SUCH, NO TECHNICAL ROOT CAUSE COULD BE IDENTIFIED IN RELATION TO THE REPORTED ISSUE. HOWEVER, THE (B)(4) EXISTS ON INJECTOMAT AGILIA RANGE CONCERNING A KNOWN "RANDOM" SOFTWARE BUG. THIS BUG MAY CAUSE THE DRUG NAME TO CHANGE UNEXPECTEDLY AFTER SYRINGE REPLACEMENT AND SYRINGE TYPE VALIDATION. THIS BEHAVIOR DOES NOT OCCUR SYSTEMATICALLY. TO ADDRESS THIS ISSUE, THE RECOMMENDED SOLUTION IS TO SELECT YES ON THE "SAME THERAPY SCREEN" SETTING, WHICH WILL DISPLAY A CONFIRMATION SCREEN AFTER EACH SYRINGE REPLACEMENT TO VERIFY THE DRUG SELECTION. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: NOT CONFIRMED. THE TREND IS: NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1199873 | INJECTOMAT MC AGILIA D | INFUSION PUMP SYSTEM | FRN | FRESENIUS VIAL S.A.S | Z018120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |