MARCOR CWP 100 H/S WTW620018003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-19 for MARCOR CWP 100 H/S WTW620018003 manufactured by Marcor.

Event Text Entries

[32221882] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058078
MDR Report Key5249589
Date Received2015-11-19
Date of Report2015-11-19
Date of Event2015-03-03
Date Added to Maude2015-11-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMARCOR
Generic NameWATER FILTERATION SYSTEM
Product CodeFIP
Date Received2015-11-19
Model NumberCWP 100 H/S
Catalog NumberWTW620018003
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMARCOR
Manufacturer AddressPLYMOUTH MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-11-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.