FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP
MDR report key: 19015886
·
Received April 1, 2024
Report
- Report Number
- 3011581906-2024-00204
- Event Type
- Malfunction
- Date Received
- April 1, 2024
- Date of Event
- February 20, 2024
- Report Date
- April 1, 2024
- Manufacturer
- INFUTRONIX, LLC
- Product Code
- FPA
- PMA / PMN Number
- K153193
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
NO INVESTIGATION OF THE DEVICE CAN BE CARRIED OUT BECAUSE THE IV ADMINISTRATION SET WILL NOT LIKELY BE RETURNED FOR EVALUATION. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 0
ON (B)(6) 2024, INFUTRONIX LLC RECEIVED A REPORT FROM A PATIENT THAT TUBING LEAKED ON THE SIDE OF THE PUMP. NO INJURY OR HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1518520 | ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |