FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 16310538
·
Received February 7, 2023
Report
- Report Number
- 3011581906-2023-00015
- Event Type
- Malfunction
- Date Received
- February 7, 2023
- Date of Event
- November 11, 2023
- Report Date
- February 7, 2023
- Manufacturer
- INFUTRONIX, LLC.
- Product Code
- FPA
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.
Description of Event or Problem · 0
A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A COMPLAINT ANALYST WHO REPORTED A LEAKING ADMINISTRATION SET. DEVICE OPERATOR WAS A CLINICAL PHARMACIST. MEDICATION BEING INFUSED WAS 5FU. 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 |
|---|---|---|---|---|---|---|---|
| 1494699 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. | HS-008 | 2210035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |