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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERIWATER LLC AMERIWATER MRO5X AMERIWATER PURIFICATION SYSTEM; SUBSYSTEM, WATER PURIFICATION
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AMERIWATER LLC AMERIWATER MRO5X AMERIWATER PURIFICATION SYSTEM; SUBSYSTEM, WATER PURIFICATION Back to Search Results
Model Number MRO5X
Device Problems Corroded (1131); Fluid/Blood Leak (1250); Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2019
Event Type  Injury  
Event Description
Water purification system for intended use in a dialysis setting has fittings that are made of brass.The brass fittings corrode and leak water.The leakage cause the membranes to lose their prime and system automatic flushing does not get initiated due to the pressure drop.The membranes and the water purification system due to not being flushed automatically stimulate bacterial growth, which becomes high and in an unacceptable numbers.There is potential that this will cause pts infections and pyrogenic reactions.The tests are performed on the purified water using bacterial colony counts in produced water for dialysis and lal (an assay that is used to estimate endotoxins in water) both tests giving numbers that are not acceptable for the product water.Fda safety report id# (b)(4).
 
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Brand Name
AMERIWATER MRO5X AMERIWATER PURIFICATION SYSTEM
Type of Device
SUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
AMERIWATER LLC
dayton OH 45414
MDR Report Key8658442
MDR Text Key146811349
Report NumberMW5087032
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMRO5X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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