Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
4 linked reportsMalfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 11.56 |
| 2019-02 | 0 | 13.35 |
| 2019-03 | 0 | 14.04 |
| 2019-04 | 0 | 14.67 |
| 2019-05 | 0 | 13.73 |
| 2019-06 | 0 | 11.2 |
| 2019-07 | 0 | 12.88 |
| 2019-08 | 0 | 17.93 |
| 2019-09 | 0 | 13.93 |
| 2019-10 | 0 | 15.12 |
| 2019-11 | 0 | 18.44 |
| 2019-12 | 0 | 25.68 |
| 2020-01 | 0 | 15.21 |
| 2020-02 | 0 | 21.44 |
| 2020-03 | 0 | 19.57 |
| 2020-04 | 0 | 21.08 |
| 2020-05 | 0 | 34.71 |
| 2020-06 | 0 | 19.38 |
| 2020-07 | 0 | 28.1 |
| 2020-08 | 0 | 33.51 |
| 2020-09 | 0 | 92.58 |
| 2020-10 | 0 | 113.47 |
| 2020-11 | 0 | 241.82 |
| 2020-12 | 0 | 493.74 |
| 2021-01 | 0 | 312.78 |
| 2021-02 | 0 | 124.55 |
| 2021-03 | 0 | 88.37 |
| 2021-04 | 0 | 90.87 |
| 2021-05 | 0 | 82.05 |
| 2021-06 | 0 | 85.82 |
| 2021-07 | 0 | 107.95 |
| 2021-08 | 0 | 138.66 |
| 2021-09 | 0 | 168.13 |
| 2021-10 | 0 | 358.71 |
| 2021-11 | 0 | 423.55 |
| 2021-12 | 0 | 1317.75 |
| 2022-01 | 0 | 2933.87 |
| 2022-02 | 0 | 1625.53 |
| 2022-03 | 0 | 2497.38 |
| 2022-04 | 0 | 2604.18 |
| 2022-05 | 0 | 2120.89 |
| 2022-06 | 0 | 2109.64 |
| 2022-07 | 0 | 967.29 |
| 2022-08 | 0 | 256.24 |
| 2022-09 | 0 | 313.05 |
| 2022-10 | 0 | 296.73 |
| 2022-11 | 0 | 274.1 |
| 2022-12 | 0 | 255.15 |
| 2023-01 | 0 | 133.96 |
| 2023-02 | 0 | 286.77 |
| 2023-03 | 0 | 331.09 |
| 2023-04 | 0 | 285.47 |
| 2023-05 | 0 | 260.64 |
| 2023-06 | 0 | 331.33 |
| 2023-07 | 0 | 330.53 |
| 2023-08 | 0 | 314.7 |
| 2023-09 | 0 | 265.98 |
| 2023-10 | 0 | 150.04 |
| 2023-11 | 0 | 141.94 |
| 2023-12 | 0 | 71.12 |
| 2024-01 | 0 | 71.6 |
| 2024-02 | 0 | 108.97 |
| 2024-03 | 0 | 78.95 |
| 2024-04 | 0 | 82.21 |
| 2024-05 | 0 | 48.37 |
| 2024-06 | 0 | 55.64 |
| 2024-07 | 0 | 51.72 |
| 2024-08 | 0 | 44.13 |
| 2024-09 | 0 | 51.99 |
| 2024-10 | 0 | 55.6 |
| 2024-11 | 0 | 61.71 |
| 2024-12 | 0 | 57.79 |
| 2025-01 | 0 | 70.59 |
| 2025-02 | 0 | 62.26 |
| 2025-03 | 0 | 93.84 |
| 2025-04 | 0 | 77.56 |
| 2025-05 | 0 | 91.64 |
| 2025-06 | 0 | 96.63 |
| 2025-07 | 0 | 127.32 |
| 2025-08 | 0 | 91.72 |
| 2025-09 | 0 | 89.34 |
| 2025-10 | 0 | 98.39 |
| 2025-11 | 2 | 90.06 |
| 2025-12 | 0 | 95.49 |
| 2026-01 | 0 | 81.49 |
| 2026-02 | 0 | 86.01 |
| 2026-03 | 2 | 95.82 |
| 2026-04 | 0 | 157.58 |
| 2026-05 | 0 | 361.57 |
| 2026-06 | 0 | 366.13 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-02 | 3000240707-2026-00076 | Malfunction | Available | exact di |
| 2026-03-02 | 3004548776-2026-00083 | Malfunction | Available | exact di |
| 2025-11-11 | 3000240707-2025-00570 | Malfunction | Available | exact di |
| 2025-11-11 | 3004548776-2025-00582 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K210074Substantially equivalent (SESE) · 2022-03-01clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-08-08 | OAI | Official action indicated | Fresenius Kabi USA, LLC | 4 |
| 2025-08-08 | OAI | Official action indicated | Fresenius Kabi USA, LLC | 4 |
| 2024-04-16 | VAI | Voluntary action indicated | Fresenius Kabi Warrendale | 0 |
| 2024-02-08 | VAI | Voluntary action indicated | Fresenius Kabi USA, LLC | 0 |
| 2024-01-04 | WL | Warning Letter | Fresenius Kabi USA, LLC | — |
| 2024-01-04 | WL | Warning Letter | Fresenius Kabi USA, LLC | — |
| 2023-09-07 | OAI | Official action indicated | Fresenius Kabi USA, LLC | 5 |
| 2023-09-07 | OAI | Official action indicated | Fresenius Kabi USA, LLC | 5 |
| 2023-08-30 | VAI | Voluntary action indicated | Fresenius Kabi USA, LLC | 1 |
| 2022-03-18 | VAI | Voluntary action indicated | Fresenius Kabi USA, LLC | 1 |
| 2022-03-18 | VAI | Voluntary action indicated | Fresenius Kabi USA, LLC | 1 |
| 2019-11-25 | NAI | No action indicated | Fresenius Kabi USA, LLC | 0 |
| 2018-12-03 | NAI | No action indicated | Fresenius Kabi USA LLC | 0 |
| 2017-09-14 | NAI | No action indicated | Fresenius Kabi Warrendale | 0 |
| 2017-08-18 | NAI | No action indicated | Fresenius Kabi USA, LLC | 0 |
| 2017-08-07 | NAI | No action indicated | Fenwal Inc | 0 |
| 2017-07-20 | NAI | No action indicated | Fresenius Kabi USA LLC | 0 |
| 2016-03-21 | NAI | No action indicated | Fenwal International Inc. | 0 |
| 2015-12-03 | NAI | No action indicated | Fresenius Hemocare Deutschland GmbH | 0 |
| 2015-05-05 | NAI | No action indicated | Fresenius Kabi Warrendale | 0 |
| 2015-01-22 | NAI | No action indicated | Fresenius Vial Sa | 0 |
| 2013-12-11 | NAI | No action indicated | Fresenius Kabi USA LLC | 3 |
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