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

Model Number ME14714

Device Problems Misconnection (1399); Misassembly by Users (3133)

Patient Problem Death (1802)

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.

• Brand Name: MILLENIUM RO SYSTEM
• Type of Device: WATER 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 Key: 6542253
• MDR Text Key: 74355500
• Report Number: 3019131-2017-00002
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: ME14714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death