FDA Adverse Event
Malfunction
Summary report: N
NIMBUS II PLUS AMBULATORY INFUSION PUMP
MDR report key: 19351966
·
Received May 20, 2024
Report
- Report Number
- 3011581906-2024-00586
- Event Type
- Malfunction
- Date Received
- May 20, 2024
- Date of Event
- April 25, 2024
- Report Date
- May 20, 2024
- Manufacturer
- INFUTRONIX, LLC
- Product Code
- FRN
- UDI-DI
- 00817170020161
- PMA / PMN Number
- K153193
- Removal / Correction Number
- Z-1285-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE PUMP'S TEST RECORD WAS REVIEWED AND ALL PREVIOUS TEST PASSED. THERE IS NO PREVIOUS COMPLAINT ON THE DEVICE. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
INFUTRONIX, LLC RECEIVED A REPORT PATIENT THAT NIMBUS PUMP SCREEN WAS BLANK AND THAT IT POWERED OFF. WHEN ATTEMPTING TO POWER BACK ON THE ONLY OPTION WAS NEW INFUSION. THE UNIT WAS POWERED BACK OFF AND THE LINE CLAMPED. THE PATIENT WAS INSTRUCTED TO GO INTO THE CLINIC TO HAVE THIS ADDRESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1542158 | NIMBUS II PLUS AMBULATORY INFUSION PUMP | AMBULATORY INFUSION PUMP | FRN | INFUTRONIX, LLC | NIMBUS II PLUS | 2206213120 | 00817170020161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Unknown |