MAUDE Adverse Event Report: MAR COR PURIFICATION 23G SERIES REVERSE OSMOSIS SYSTEM; WATER PURIFICATION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cramp(s) (2193); Dizziness (2194)

Event Date 03/09/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported 6-8 patients becoming sick during dialysis treatment using the 23g reverse osmosis water purification system.All patient treatments were discontinued and one patient sought medical attention after presenting symptoms of dizziness and cramps.In communication with mar cor purification field service technician, the facility's nurse manager reported high chlorine levels were detected in the product water at the end of the loop (post ro system).Mar cor purification field service technician visited the facility the following day and performed a complete check of the water room equipment.Chlorine tests were performed on primary and secondary carbon filters as well as the end of the loop.All results showed the system was operating within specification.Mar cor purification regulatory followed up with the facility's nurse manager and it was confirmed that the system was operating normally and there have been no issues since the reported incident.The cause of the patients becoming sick has not been determined.The nurse manager confirmed all the patients are doing fine and are continuing treatment.Mar cor purification has received no similar complaints, indicating this is an isolated, site-specific incident.This complaint will continue being monitored in the mar cor purification complaint handling system.

Event Description

The facility reported 6-8 patients becoming sick during dialysis treatment using the 23g reverse osmosis water purification system.All patient treatments were discontinued and one patient sought medical attention after presenting symptoms of dizziness and cramps.

• Brand Name: 23G SERIES REVERSE OSMOSIS SYSTEM
• Type of Device: WATER PURIFICATION SYSTEM
• Manufacturer (Section D): MAR COR PURIFICATION; 14550 28th ave n.; plymouth MN 55447
• Manufacturer (Section G): MAR COR PURIFICATION; 14550 28th ave. n.; plymouth MN 55447
• Manufacturer Contact: alex nelson ; 14550 28th ave. n.; plymouth, MN 55447 ; 7635094799
• MDR Report Key: 8471404
• MDR Text Key: 140549334
• Report Number: 3019131-2019-00005
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other