MAUDE Adverse Event Report: MAR COR PURIFICATION MILLENIUM HX; WATER PURIFICATION SYSTEM

Medical Device Problem Codes	Inadequate Filtration Process (2308); Device Handling Problem (3265); Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Codes	Anemia (1706); Hemolysis (1886); Hemolytic Anemia (2279)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient's dialysis clinic reported the patient was hospitalized and evaluated for possible hemolysis and chlorine exposure after receiving home dialysis treatment in which a millenium hx portable reverse osmosis water purification system was in use.Mar cor purification was contacted by the dialysis clinic to help assess the millenium hx ro system after the patient's nephrologist ordered the patient's home equipment to be removed from the home and tested.Before removing the equipment from the patient's home, the clinic biomedical technician tested and confirmed total chlorine levels in the water post carbon tanks and ro system exceeded the maximum limit of 0.1 ppm.It was then identified by the dialysis clinic personnel and mar cor purification technical specialists that the primary and secondary carbon filters were not properly installed in the carbon block filtration system by the facility's biomedical technician which resulted in chlorine breakthrough during treatments.The dialysis clinic provided mar cor purification with their fda medwatch report #s 5526870000-2019-0001 and 5526870000-2019-0002 submitted 19 february 2019.Per the millenium hx ro system user manual and aami, csa and centers for medicare & medicaid services (cms) standards, verification of the absence of chlorine (< 0.1 ppm) must be performed before ro product water is used for any patient related uses to prevent damage to the ro membrane and injury to patients.Users are required to record the chlorine concentrations in their pretreatment log before each treatment.It was reported that when completing chlorine testing at home, the patient noticed chlorine results greater than 0.1 ppm but did not record the results accurately on his treatment sheet, or report the out of range results to the nurse or biomedical technician.After correcting the position of the carbon filters in the filtration system, mar cor purification technical specialists evaluated the patient's home equipment with clinic personnel and confirmed the millenium hx ro systems are operating according to specification.It was reported that the patient is currently fine and is continuing dialysis treatments in-center at the dialysis clinic.This complaint will continue being monitored in the mar cor purification complaint handling system.
Event or Problem Description
A patient's dialysis clinic reported the patient was hospitalized and evaluated for possible hemolysis and chlorine exposure after receiving home dialysis treatment in which a millenium hx portable reverse osmosis water purification system was in use.

• Brand Name: MILLENIUM HX
• Common Device Name: WATER PURIFICATION SYSTEM
• Manufacturer (Section D): MAR COR PURIFICATION; 14550 28th ave. n.; plymouth MN 55447
• MDR Report Key: 8426090
• Report Number: 3019131-2019-00004
• Device Sequence Number: 14015591
• Product Code: FIP
• UDI-Device Identifier: 00817492020771
• UDI-Public: 00817492020771
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS K@HOME DIALYSIS MACHINE; PENTAIR CARBON FILTER CHLORPLUS 20BB
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 47 YR
• Patient Weight: 95