FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 15230320
·
Received August 15, 2022
Report
- Report Number
- 3011581906-2022-00108
- Event Type
- Malfunction
- Date Received
- August 15, 2022
- Date of Event
- July 15, 2022
- Report Date
- August 15, 2022
- Manufacturer
- INFUTRONIX, LLC.
- Product Code
- FPA
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED FOR EVALUATION.
Description of Event or Problem · 0
ON 07/18/2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-008-B LOT 2103004 SET CAME DISCONNECTED FROM THE CASSETTE AND CAUSED A LEAK." THE LEAK TOOK PLACE DURING AN INFUSION. DEVICE OPERATOR WAS A NURSE. MEDICATION INFUSED WAS 5FU. 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 |
|---|---|---|---|---|---|---|---|
| 1237446 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC. | 2103004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |