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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION, INC. WRO 300H DIALYSIS WATER SYSTEM SUBSYSTEM, WATER PURIFICATION

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MAR COR PURIFICATION, INC. WRO 300H DIALYSIS WATER SYSTEM SUBSYSTEM, WATER PURIFICATION Back to Search Results
Model Number RO,WRO 300 H,115V~,60HZ
Device Problems Contamination /Decontamination Problem (2895); Device Contamination With Biological Material (2908)
Patient Problem No Information (3190)
Event Date 01/16/2017
Event Type  malfunction  
Event Description
Portable hemodialysis (water treatment) reverse osmosis(ro) are cultured and tested for endotoxins monthly. In the beginning of the year, all portable ro machines; marcor model wro300h were pulled from use due to culture and endotoxin results. Contacted the manufacturer to see what can be done to eliminate frequent positive cultures. Recommended to increase heat disinfectant process from 2x/week to once per day. With new process, all ros had no growth in past two months.
 
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Brand NameWRO 300H DIALYSIS WATER SYSTEM
Type of DeviceSUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
MAR COR PURIFICATION, INC.
14550 28th avenue north
minneapolis MN 55447
MDR Report Key6471592
MDR Text Key72096118
Report Number6471592
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRO,WRO 300 H,115V~,60HZ
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2017
Event Location Hospital
Date Report to Manufacturer03/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/07/2017 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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