MAUDE Adverse Event Report: AMERIWATER LLC CENTURION BY AMERIWATER (F26) REVERSE OSMOSIS UNIT SUBSYSTEM, WATER PURIFICATION

Model Number RO-68860/DV08E

Device Problem Defective Component (2292)

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

Event Date 04/15/2019

Event Type  Injury  

Event Description

Dialysis machine malfunctioned and therapy had to be stopped. Sled therapy restarted with new machine. Delay in therapy while switching machines.

• Brand Name: CENTURION BY AMERIWATER (F26) REVERSE OSMOSIS UNIT
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): AMERIWATER LLC; dayton OH
• MDR Report Key: 8764186
• MDR Text Key: 150312979
• Report Number: MW5087889
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: RO-68860/DV08E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 07/03/2019 Patient Sequence Number: 1