• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION MILLENIUM RO SYSTEM WATER PURIFICATION SYSTEMS AND PORTABLE REVERSE OSMOSIS SYSTEMS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAR COR PURIFICATION MILLENIUM RO SYSTEM WATER PURIFICATION SYSTEMS AND PORTABLE REVERSE OSMOSIS SYSTEMS Back to Search Results
Model Number ME14714
Device Problems Misconnection; Misassembly by Users
Event Date 04/06/2017
Event Type  Death  
Manufacturer Narrative

The dialysis facility reported that the patient was dialyzed utilizing water that had not been processed by the portable ro system. User error is suspected as the facility accidentally connected the water hose on the dialysis machine to the disinfect port instead of the ro product water output port. Disinfectant was not attached to the hose or in the machine at the time of the incident. The patient was reported to have been on life support prior to dialysis treatment. Sometime after dialysis, the patient was removed from life support and died. The ro machine has since been quarantined, though there was no reported machine malfunction or reported correlation between the end of dialysis treatment and the patient death. The facility confirmed the feed water that was connected to the wrong port on the machine was dechlorinated and tested prior to the dialysis treatment. This complaint will continue to be monitored in mar cor purification complaint system. Device not returned to manufacturer.

 
Event Description

User facility reported that a patient was being dialyzed with ro feed water. The ro system's water hose was connected to the wrong output port, thus water used in dialysis was not ro water. It has been reported to mcp the patient was on life support prior to dialysis treatment. Sometime after dialysis treatment (unknown amount of time), the patient was removed from life support and subsequently died.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMILLENIUM RO SYSTEM
Type of DeviceWATER PURIFICATION SYSTEMS AND PORTABLE REVERSE OSMOSIS SYSTEMS
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 Key6542253
Report Number3019131-2017-00002
Device Sequence Number1
Product CodeFIP
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Other
Type of Report Initial
Report Date 05/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2017
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberME14714
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2003
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: 05/03/2017 Patient Sequence Number: 1
-
-