MAUDE Adverse Event Report: AMERIWATER AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS; SUBSYSTEM, WATER PURIFICATION

Model Number MRO5

Device Problems Corroded (1131); Leak/Splash (1354); Microbial Contamination of Device (2303)

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

Event Date 04/27/2019

Event Type  Injury  

Event Description

Reverse osmosis machine constantly leaking due to corrosion in fittings made from brass.This leaded to high microbial to high microbial and lal count in product water used to dialyze pts.Fda safety report id# (b)(4).

• Brand Name: AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): AMERIWATER ; 1257 stanley ave ; dayton OH 45404
• MDR Report Key: 8632108
• MDR Text Key: 145972012
• Report Number: MW5086815
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MRO5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention