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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION MILLENIUM HX WATER PURIFICATION SYSTEM

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MAR COR PURIFICATION MILLENIUM HX WATER PURIFICATION SYSTEM Back to Search Results
Device Problems Material Disintegration (1177); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2019
Event Type  Injury  
Manufacturer Narrative
The facility reported observing a brown substance on the reverse osmosis (ro) membrane in their millenium hx portable ro system. There is potential for patient or user exposure. The facility immediately replaced the affected membrane in their ro system and has not experienced any issues. The source of the brown substance was confirmed to be the adhesive used in the construction of the membrane itself. It is unknown if the substance is entering the ro system fluid pathway. Additional testing and investigation is underway. This is the first instance of a brown substance ever reported to mar cor purification. There have been no reports of any patient adverse effects. This report is being submitted conservatively as the potential for patient or user exposure to the substance is unknown at this time. This complaint will continue being monitored in the mar cor purification/cantel complaint handling system.
 
Event Description
The facility reported observing a brown substance on the reverse osmosis (ro) membrane in their millenium hx portable ro system. There is potential for patient or user exposure.
 
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Brand NameMILLENIUM HX
Type of DeviceWATER PURIFICATION 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
alex nelson
14550 28th avenue north
minneapolis, MN 55447
7635094799
MDR Report Key8345659
MDR Text Key136447369
Report Number3019131-2019-00001
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/15/2019 Patient Sequence Number: 1
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