MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-15 for MILLENIUM HX manufactured by Mar Cor Purification.
[138973903]
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.
Patient Sequence No: 1, Text Type: N, H10
[138973904]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2019-00004 |
| MDR Report Key | 8426090 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2016-06-03 |
| Date Added to Maude | 2019-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALEX NELSON |
| Manufacturer Street | 14550 28TH AVE. N. |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVE. N. |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLENIUM HX |
| Generic Name | WATER PURIFICATION SYSTEM |
| Product Code | FIP |
| Date Received | 2019-03-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVE. N. PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-15 |