FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 15574633
·
Received October 11, 2022
Report
- Report Number
- 3011581906-2022-00186
- Event Type
- Malfunction
- Date Received
- October 11, 2022
- Date of Event
- September 12, 2022
- Report Date
- October 4, 2022
- Manufacturer
- INFUTRONIX, LLC.
- Product Code
- FPA
- UDI-DI
- 00817170020017
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
RETURN OF THE DEVICE WAS REQUESTED, BUT THE REPORTER HEALTHCARE PROFESSIONAL CONFIRMED THAT THE DEVICE WAS DISCARDED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 0
INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A PATIENT: "A PUMP LEAK" AROUND A BLUE VALVE. PATIENT COULD NOT SPECIFY THE EXACT SOURCE OF THE LEAK. PATIENT WAS INSTRUCTED TO TURN THE PUMP OFF AND CLAMP THE LINE. DEVICE OPERATOR WAS THE PATIENT. 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 |
|---|---|---|---|---|---|---|---|
| 2897687 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. | HS-001 | 2106002 | 00817170020017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female |