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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERIWATER LLC CENTURION BY AMERIWATER (F26) REVERSE OSMOSIS UNIT SUBSYSTEM, WATER PURIFICATION

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AMERIWATER LLC CENTURION BY AMERIWATER (F26) REVERSE OSMOSIS UNIT SUBSYSTEM, WATER PURIFICATION Back to Search Results
Model Number RO-68860/DV08E
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2019
Event Type  Injury  
Event Description
Dialysis machine malfunctioned and therapy had to be stopped. Sled therapy restarted with new machine. Delay in therapy while switching machines.
 
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Brand NameCENTURION BY AMERIWATER (F26) REVERSE OSMOSIS UNIT
Type of DeviceSUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
AMERIWATER LLC
dayton OH
MDR Report Key8764186
MDR Text Key150312979
Report NumberMW5087889
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 Risk Manager
Type of Report Initial
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRO-68860/DV08E
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?
Type of Device Usage

Patient Treatment Data
Date Received: 07/03/2019 Patient Sequence Number: 1
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