FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 11159225
·
Received January 13, 2021
Report
- Report Number
- 3011581906-2020-00109
- Event Type
- Malfunction
- Date Received
- January 13, 2021
- Date of Event
- February 16, 2020
- Report Date
- January 11, 2021
- Manufacturer
- INFUTRONIX, LLC
- Product Code
- FPA
- UDI-DI
- 00817170020048
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ON 12/17/2020, INFUTRONIX CONFIRMED WITH THE DISTRIBUTOR THAT THE AFFECTED DEVICE WAS NEVER RETURNED FOR EVALUATION AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THIS MDR IS A RESULT OF COMPLAINT REMEDIATION EFFORT.
Description of Event or Problem · 1
ON 12/17/2020, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "THERE WAS A BIT OF LEAKAGE. NO KNOWN AREA WHERE LEAKING CAME FROM." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63502 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC | HS-002 | UNKNOWN | 00817170020048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |