FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 15558665
·
Received October 7, 2022
Report
- Report Number
- 3011581906-2022-00181
- Event Type
- Malfunction
- Date Received
- October 7, 2022
- Date of Event
- September 5, 2022
- Report Date
- October 3, 2022
- Manufacturer
- INFUTRONIX, LLC.
- Product Code
- FPA
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
RETURN OF THE DEVICE WAS REQUESTED, BUT THE REPORTER CONFIRMED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 0
INFUTRONIX RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE: "TUBING DISCONNECTED FROM THE CASSETTE AND IT LEAKED MEDICATION DURING A PATIENTS INFUSION." DEVICE OPERATOR WAS A NURSE. MEDICATION BEING INFUSED WAS 5FU. THERE WAS NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2856298 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |