MAUDE Adverse Event Report: MAR COR PURIFICATION, INC. WRO 300H; SUBSYSTEM, WATER PURIFICATION

Model Number RO,WRO 300 H,115V~,60HZ

Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2022

Event Type  malfunction  

Event Description

Patient was started on dialysis in the icu, shortly after starting the ro started to alarm, "conductivity alarm".It would silence and the patient continued to run without an issue while the tech brought up a new ro and the patient was rinsed back and her machine was hooked up to the new ro and she was re-started on new ro and completed dialysis without further issues.Htm replaced membrane, and put back in service.Will not be returning device.

• Brand Name: WRO 300H
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): MAR COR PURIFICATION, INC.; 14550 28th avenue north; minneapolis MN 55447
• MDR Report Key: 14436562
• MDR Text Key: 292054887
• Report Number: 14436562
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RO,WRO 300 H,115V~,60HZ
• 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: 05/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1