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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION CWP REVERSE OSMOSIS SYSTEM

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MAR COR PURIFICATION CWP REVERSE OSMOSIS SYSTEM Back to Search Results
Model Number 101366
Device Problems Solenoid; Overheating of Device; Water Purification System
Event Date 05/16/2015
Event Type  Malfunction  
Manufacturer Narrative

New information provided by clinic on 11/19/2015, user report mw5058085. A clinic employee pulled the fire alarm when smoke was noticed in the water room, not the patient area. Ro unit was repaired and patients resumed treatment after an approximate 15 minute delay. To date, there have been no reports of illness or injury. This complaint will continue to be monitored in the mar cor complaint handling system. Solenoid valve disposed of by user.

 
Event Description

On (b)(6) 2015 dialysis clinic informed mar cor that their inlet solenoid coil stopped functioning on (b)(6) 2015. A 15 minute delay of patient treatment for 10 patients was reported while repairs were performed.

 
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Brand NameCWP
Type of DeviceREVERSE OSMOSIS SYSTEM
Manufacturer (Section D)
MAR COR PURIFICATION
14550 28th avenue north
minneapolis MN 55447
Manufacturer (Section G)
MAR COR PURIFICATION
14550 28th avenue north
minneapolis MN 55447
Manufacturer Contact
megan dickey
14550 28th avenue north
minneapolis , MN 55447
7635533300
MDR Report Key5332485
Report Number3019131-2015-00006
Device Sequence Number1
Product CodeFIP
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 12/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number101366
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/19/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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