MAUDE Adverse Event Report: MAR COR PURIFICATION REVERSE OSMOSIS SYSTEM; CENTRAL WATER TREATMENT SYSTEM

Model Number CWP

Device Problems Electrical /Electronic Property Problem (1198); Melted (1385)

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

Event Date 02/21/2012

Event Type  malfunction  

Event Description

After hours, central water plant (cwp) pump experienced electical problems causing pump to melt down.

Manufacturer Narrative

Mar cor purification brought in an offsite engineering and forensic services company to determine the root cause of failure of cwp pumps.Testing performed: visually examined and took digital x-rays of the pump assembly electrical risers to determine the condition of the connectors prior to disassembly.Root cause determined to be the power cable crimp connection.This part was involved in a series of resistive heating events, that compromised the conductor and connector insulation, which eventually lead to a ground fault/short.Mar cor purification's engineering team redesigned the entire electrical assembly and removed the manual crimps.This design was then implemented immediately into manufacturing process of the entire central water plant (cwp).There was also an analysis of the problem population of cwps currently at facility/user locations.Updates and repairs are currently in-process for cwp machines installed by or manufactured by mar cor purification.Gambro was the original designer of the cwp which mar cor purchased the rights to manufacturer for us distribution.Mar cor purification will continue to monitor this complaint within the complaint system.

• Brand Name: REVERSE OSMOSIS SYSTEM
• Type of Device: CENTRAL WATER TREATMENT SYSTEM
• Manufacturer (Section D): MAR COR PURIFICATION; 14550 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MAR COR PURIFICATION; 14550 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14550 28th ave n; minneapolis, MN 55447 ; 7635533300
• MDR Report Key: 3628212
• MDR Text Key: 18855726
• Report Number: 3019131-2014-00007
• 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: Replace
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CWP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 02/21/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2010
• 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