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

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. 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.

• Brand Name: MILLENIUM HX
• Type of Device: WATER 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 Key: 8345765
• MDR Text Key: 136457932
• Report Number: 3019131-2019-00002
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110578
• Number of Events Reported: 1
• 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 Received: 02/15/2019
• 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 Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• 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