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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION MILLENIUM HX; WATER PURIFICATION SYSTEM
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MAR COR PURIFICATION MILLENIUM HX; WATER PURIFICATION SYSTEM Back to Search Results
Device Problems Inadequate Filtration Process (2308); Device Handling Problem (3265); Misassembly During Maintenance/Repair (4054)
Patient Problems Anemia (1706); Hemolysis (1886); Hemolytic Anemia (2279)
Event Date 02/22/2019
Event Type  Injury  
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 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.
 
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Brand Name
MILLENIUM HX
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 Key8426090
MDR Text Key138973903
Report Number3019131-2019-00004
Device Sequence Number1
Product Code FIP
UDI-Device Identifier00817492020771
UDI-Public00817492020771
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
FRESENIUS K@HOME DIALYSIS MACHINE; PENTAIR CARBON FILTER CHLORPLUS 20BB
Patient Outcome(s) Hospitalization;
Patient Age47 YR
Patient Weight95
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