MAUDE Adverse Event Report: MAR COR PURIFICATION CWP; REVERSE OSMOSIS SYSTEM

Model Number 101366

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2015

Event Type  malfunction  

Manufacturer Narrative

New information provided by clinic on 11/19/2015, user report mw5058085.A clinic employee pulled the fire alarm when smoke was noticed in the water room, not the patient area.Ro unit was repaired and patients resumed treatment after an approximate 15 minute delay.To date, there have been no reports of illness or injury.This complaint will continue to be monitored in the mar cor complaint handling system.Solenoid valve disposed of by user.

Event Description

On (b)(6) 2015 dialysis clinic informed mar cor that their inlet solenoid coil stopped functioning on (b)(6) 2015.A 15 minute delay of patient treatment for 10 patients was reported while repairs were performed.

• Brand Name: CWP
• Type of Device: REVERSE OSMOSIS 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: megan dickey ; 14550 28th avenue north; minneapolis, MN 55447 ; 7635533300
• MDR Report Key: 5332485
• MDR Text Key: 34594411
• Report Number: 3019131-2015-00006
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 101366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1