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

Model Number CWP 101H

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2021

Event Type  malfunction  

Event Description

At 1400, the main reverse osmosis (ro) went into alarm mode (red light flashing), dialysis machine alarmed "no water". Rinseback attempted on patient, but then dialysis machine alarms "general safe state". Manual rinseback started. Patient was unable to be rinsed back. Maintenance/biomed called. Md notified of patients hd treatments being discontinued 50 minutes early. Manufacturer response for water purification system, ro, mar cor purification (per site reporter): thermal sensor was under warranty from manufacturer.

• Brand Name: CWP
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): MAR COR PURIFICATION, INC.; 14550 28th ave n; plymouth MN 55447
• MDR Report Key: 11378562
• MDR Text Key: 233496996
• Report Number: 11378562
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2021,01/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CWP 101H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2021
• Device Age: 6 YR
• Event Location: No Information
• Date Report to Manufacturer: 02/25/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown