ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
Report
- Report Number
- 3011581906-2022-00008
- Event Type
- Malfunction
- Date Received
- February 15, 2022
- Report Date
- February 15, 2022
- Manufacturer
- INFUTRONIX, LLC.
- Product Code
- FPA
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ON (B)(6) 2022, INFUTRONIX SERVICE PROVIDER CONFIRMED FROM THE END USER THAT THE AFFECTED DEVICE WAS DISCARDED AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THE COMPLAINT COULD NOT BE CONFIRMED.
ON (B)(6) 2022, INFUTRONIX SERVICE PROVIDER CONFIRMED FROM THE END USER THAT THE AFFECTED DEVICE WAS DISCARDED AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THE COMPLAINT COULD NOT BE CONFIRMED.
ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-008, LOT 2006015, SET CAME APART AT THE CASSETTE, THIS WAS A BONDING ISSUE. THIS OCCURRED DURING AN INFUSION WHILE THE PATIENT WAS AT HOME." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.
ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-008, LOT 2006015, SET CAME APART AT THE CASSETTE, THIS WAS A BONDING ISSUE. THIS OCCURRED DURING AN INFUSION WHILE THE PATIENT WAS AT HOME." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) MEDICAL CO. LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 528695 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. | 2006015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |