MAUDE Adverse Event Report: MAR COR PURIFICATION, INC. CWP 100 SUBSYSTEM, WATER PURIFICATION

Model Number RO, CWP, 28 LPM, 104H

Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2017

Event Type  malfunction  

Event Description

For about 2 weeks, it was reported that there had been repetitive low level inlet pressure alarms overnight and the green operations indicator light would not come on. Due to these issues, the water purification unit could not be used and the back-up deionization system was used to purify the water. The system was serviced by the manufacturer 4 times during the 2 week period. Services performed by the manufacturer included changing the pre-treatment back wash timer settings, replacing the low level switch for the hot water tank, tightening the jumper bar, and replacing valve 64. Reportedly, the water purification unit has not had any issues since the last service when the jumper bar was tightened. Reportedly, no harm occurred to patients during the 2 week period.

• Brand Name: CWP 100
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): MAR COR PURIFICATION, INC.; 14550 28th avenue north; minneapolis MN 55447
• MDR Report Key: 6405704
• MDR Text Key: 69978622
• Report Number: 6405704
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: RO, CWP, 28 LPM, 104H
• Other Device ID Number: 100474
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2017
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage