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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERIWATER AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS SUBSYSTEM, WATER PURIFICATION

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AMERIWATER AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS SUBSYSTEM, WATER PURIFICATION Back to Search Results
Model Number MRO5
Device Problems Corroded (1131); Leak/Splash (1354); Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2019
Event Type  Injury  
Event Description
Reverse osmosis machine constantly leaking due to corrosion in fittings made from brass. This leaded to high microbial to high microbial and lal count in product water used to dialyze pts. Fda safety report id# (b)(4).
 
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Brand NameAMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Type of DeviceSUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
AMERIWATER
1257 stanley ave
dayton OH 45404
MDR Report Key8632108
MDR Text Key145972012
Report NumberMW5086815
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 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMRO5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/21/2019 Patient Sequence Number: 1
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