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

Medical Device Problem Codes	Material Disintegration (1177); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: MILLENIUM HX
• Common Device Name: WATER PURIFICATION SYSTEM
• Manufacturer (Section D): MAR COR PURIFICATION; 14550 28th avenue north; minneapolis MN 55447
• MDR Report Key: 8345659
• Report Number: 3019131-2019-00001
• Device Sequence Number: 16624639
• Product Code: FIP
• UDI-Device Identifier: 00817492020771
• UDI-Public: 00817492020771
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K110578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other