FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 15555217
·
Received October 6, 2022
Report
- Report Number
- 3011581906-2022-00180
- Event Type
- Malfunction
- Date Received
- October 6, 2022
- Date of Event
- September 7, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.
Description of Event or Problem · 0
USER FACILITY REPRESENTATIVE REPORTED AN ADMINISTRATION SET "CAME APART FROM THE CASSETTE AND SOAKED THE PUMP 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 (B)(4) MEDICAL CO. LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1003893 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. | 2203016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |