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AquaBplus & AquaBplus B2 & AquaBplus HF
VIVONIC GmbH · Model 2000 · UDI-DI 04251285200210
FIP
Prescription
10
510(k) clearances
696
Adverse events (9 deaths)
15
Recalls
58
Facilities
Description
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-16 | Fresenius Medical Care Holdings, Inc. | Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit ex |
| 2023-01-24 | Outset Medical, Inc. | An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process. |
| 2022-06-21 | Fresenius Medical Care Holdings, Inc. | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| 2022-06-21 | Fresenius Medical Care Holdings, Inc. | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| 2022-06-16 | Fresenius Medical Care Holdings, Inc. | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting elect |
| 2022-06-16 | Fresenius Medical Care Holdings, Inc. | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting elect |
| 2021-08-03 | Fresenius Medical Care Holdings, Inc. | AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combi |
| 2021-03-18 | Fresenius Medical Care Holdings, Inc. | AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combi |
| 2020-09-01 | Fresenius Medical Care Holdings, Inc. | Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections |
| 2014-04-24 | Mar Cor Purification | Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.