FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 14687977
·
Received June 14, 2022
Report
- Report Number
- 3011581906-2022-00080
- Event Type
- Malfunction
- Date Received
- June 14, 2022
- Date of Event
- May 18, 2022
- Report Date
- June 14, 2022
- Manufacturer
- INFUTRONIX, LLC.
- Product Code
- FPA
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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
ON 05/18/2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER THAT THE ADMINISTRATION SET BROKE FROM THE DISTAL END. DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE EVENT TOOK PLACE DURING AN INFUSION. 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 |
|---|---|---|---|---|---|---|---|
| 1489760 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. | 2012003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Unknown |