FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 14107475
·
Received April 13, 2022
Report
- Report Number
- 3011581906-2022-00048
- Event Type
- Malfunction
- Date Received
- April 13, 2022
- Date of Event
- March 22, 2022
- Report Date
- April 12, 2022
- Manufacturer
- INFUTRONIX, LLC
- Product Code
- FPA
- 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 RESPONSE FROM THE END USER REGARDING THE DEVICE RETURN STATUS.
Description of Event or Problem · 0
ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "I NOTICED THE BLACK BAG WAS WET AND HAD WHITE SEDIMENT ON IT." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710015 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC | 2012003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |