FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 15112566
·
Received July 27, 2022
Report
- Report Number
- 3011581906-2022-00100
- Event Type
- Malfunction
- Date Received
- July 27, 2022
- Date of Event
- June 28, 2022
- Report Date
- July 25, 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
- 003
Narratives
Additional Manufacturer Narrative · 0
INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED FOR EVALUATION.
Description of Event or Problem · 0
ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "THE ADMIN SET TUBING COMPLETELY CAME OUT FROM THE DISTAL END OF THE CASSETTE." THE DISCONNECT OCCURRED DURING INFUSION. DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. 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 |
|---|---|---|---|---|---|---|---|
| 2033153 | 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 |