Ivenix, Inc.
Large Volume Pump (LVP) Software (order 1 per pump), version 2.0
5manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Fresenius Kabi AB, Sweden |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Record published | 2020-08-06 |
| Record revised | 2023-08-21 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2021-03-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BKT-0004 | In distribution | |
| 2.0 | Withdrawn | |
| LVP-0003 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210074 | 2022-03-01 |
| K210073 | 2022-03-01 |
| K121613 | 2013-05-01 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | UDI-DI | 2026-05-06 | Class I | Software design (manufacturing process) | Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power. | 32 systems | |
| Fresenius Kabi USA, LLC | UDI-DI | 2025-11-21 | Class II | Use error | Emphasizing instructions for LVP duration programming located in the IFU. | 30 units | |
| Fresenius Kabi USA, LLC | UDI-DI | 2025-11-14 | Class I | Software design | Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. | 30 units | |
| Fresenius Kabi USA, LLC | UDI-DI | 2025-01-10 | Class I | Software Design Change | Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infus | 23 systems | |
| Fresenius Kabi USA, LLC | UDI-DI | 2024-08-30 | Class I | Software design | The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death. | 17 units | |
| Fresenius Kabi USA, LLC | UDI-DI | 2024-03-07 | Class I | Software Design Change | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. | 17 units | |
| Fresenius Kabi USA, LLC | UDI-DI | 2023-05-10 | Class II | Software design | Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) | 6 US | |
| Fresenius Kabi USA, LLC | UDI-DI | 2022-09-16 | Class II | Software design | Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. | 3 | |
| Fresenius Kabi USA, LLC | UDI-DI | 2022-09-08 | Class I | Software design | The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm | 4 instances | 2024-09-10 |
| Fresenius Kabi USA, LLC | UDI-DI | 2022-04-22 | Class II | Device Design | Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administ | 1344 pumps |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.