FDA Adverse Event
Malfunction
Summary report: N
VOLUMAT MC AGILIA US
MDR report key: 19316019
·
Received May 14, 2024
Report
- Report Number
- 3004548776-2024-00160
- Event Type
- Malfunction
- Date Received
- May 14, 2024
- Date of Event
- April 16, 2024
- Report Date
- May 14, 2024
- Manufacturer
- FRESENIUS VIAL S.A.S.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTING THE DEVICE IS DUE FOR A PM. HE/CUSTOMER ALSO HAVING ISSUES WITH IV PUMP OVERDUE FOR ITS FACTORY PM. DURING THE IV PUMPS PM, THE MEASURED AVERAGE FLOW RATE FAILED AT: 94.94 ML/HR. ALSO DURING PM, THE MEASURED VOLUME FAILED AT: 23.53 ML. PLEASE REPAIR/CALIBRATE DEFECTIVE IV PUMP. ADDITIONAL INFO FROM FRESENIUS KABI US SERVICE: RECEIVED PUMP (B)(6). DEVICE DUE FOR PREVENTIVE MAINTENANCE. REPLACED BATTERY PACK AND MEMBRANE. FLOW RATE AND PRESSURE SENSORS REQUIRED CALIBRATION. NEW PM DUE DATE IS 05/092027. EQUIPMENT CLEANED, POST SERVICE TESTED AND RELEASED FOR USE. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 482639 | VOLUMAT MC AGILIA US | INFUSION PUMP SYSTEM | FRN | FRESENIUS VIAL S.A.S. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |