FDA Adverse Event
Malfunction
Summary report: N
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
MDR report key: 13643254
·
Received March 1, 2022
Report
- Report Number
- 3011581906-2022-00017
- Event Type
- Malfunction
- Date Received
- March 1, 2022
- Date of Event
- January 28, 2022
- Report Date
- April 29, 2022
- Manufacturer
- INFUTRONIX, LLC
- Product Code
- FPA
- UDI-DI
- 00817170020024
- PMA / PMN Number
- K153193
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative · 0
ON 04/22/2022, INFUTRONIX CONFIRMED WITH THE SERVICE PROVIDER THAT THE AFFECTED DEVICE WAS NEVER RETURNED FOR EVALUATION AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THE REPORTED ISSUE WAS NOT CONFIRMED.
Description of Event or Problem · 0
ON(B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-003, LOT 2004017 WAS LEAKING FROM A SMALL HOLE IN THE TUBING." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.
Description of Event or Problem · 0
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2022-00017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2153418 | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP | IV ADMINISTRATION SET | FPA | INFUTRONIX, LLC | HS-003 | 2004017 | 00817170020024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |