FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 15540267
·
Received October 4, 2022
Report
- Report Number
- 3011581906-2022-00175
- Event Type
- Malfunction
- Date Received
- October 4, 2022
- Report Date
- September 29, 2022
- 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
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
RETURN OF THE DEVICE WAS REQUESTED, BUT THE REPORTER CONFIRMED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 0
A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM USER FACILITY REPRESENTATIVE "THE CASSETTE TUBING ON PUMP BECAME DISCONNECTED SEVERAL TIMES DURING THE INFUSION." DEVICE OPERATOR WAS UNKNOWN. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (B)(6) MEDICAL CO. LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2857081 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. | HS-002 | 00817170020048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |