MAUDE Adverse Event Report: MARCOR MARCOR; WATER FILTERATION SYSTEM

Model Number CWP 100 H/S

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 at 1445, the renal dialysis department staff at the desk noted the computer screen went out and the water alarm lights were not on and within seconds all of the kd machines starting alarming "no water source." the staff immediately went to the water treatment room where they saw smoke and a harsh burning smell.They pulled the fire alarm at 1445.All smoke was confined to the water treatment room.There was some smell in the unit and in the hallway outside the unit.The (b)(6) came to the unit and gave direction as to the care of the pt.Five staff were present.Six pts who were done with their run or within 15-20 minutes of being done were taken off the machines and the other 4 pts were also taken off the machine.Those who were still connected to the machine had a "rinse back" or return of the blood to the pt from the tubing per physician order.Plant ops staff arrived and the defective part was located, removed, replaced with a new part and the water treatment system started again.It was determined that the solenoid coil for the inlet valve on the reverse osmosis unit failed due to overheating, shutting down the water treatment system, melting the plastic cover, which caused the smoke.Part #wtw620018003 (marcor) was replaced by plant operations maintenance technician with in-stock part.The city fire department arrived and assessed the situation.By approx 1515, the readings from the water system were recorded.Four machines were rinsed and new tubing inserted and pt runs began again by 1530 for the remaining four pts.Pts were notified of the incident.No pts were removed from the unit.Approximate 30 minutes delay occurred in the pt runs.

• Brand Name: MARCOR
• Type of Device: WATER FILTERATION SYSTEM
• Manufacturer (Section D): MARCOR; plymouth MN 55447
• MDR Report Key: 5249589
• MDR Text Key: 32221882
• Report Number: MW5058078
• Device Sequence Number: 1
• Product Code: FIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CWP 100 H/S
• Device Catalogue Number: WTW620018003
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention