Subsystem, Water Purification

US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis

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 exceeded") concentrate pressure is too high and stops the dialysis water supply.

Outset Tablo

An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.

AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems.

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems.

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

AquaC UNO H [120V, 60Hz, 1700VA,

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 electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

AquaC UNO H [120V, 60Hz, 1000VA,

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 electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106.

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 specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water.

Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975.

High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.

Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.

AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com.

The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.