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 2017-05-03 for MILLENIUM RO SYSTEM ME14714 manufactured by Mar Cor Purification.
[74355500]
The dialysis facility reported that the patient was dialyzed utilizing water that had not been processed by the portable ro system. User error is suspected as the facility accidentally connected the water hose on the dialysis machine to the disinfect port instead of the ro product water output port. Disinfectant was not attached to the hose or in the machine at the time of the incident. The patient was reported to have been on life support prior to dialysis treatment. Sometime after dialysis, the patient was removed from life support and died. The ro machine has since been quarantined, though there was no reported machine malfunction or reported correlation between the end of dialysis treatment and the patient death. The facility confirmed the feed water that was connected to the wrong port on the machine was dechlorinated and tested prior to the dialysis treatment. This complaint will continue to be monitored in mar cor purification complaint system. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[74355501]
User facility reported that a patient was being dialyzed with ro feed water. The ro system's water hose was connected to the wrong output port, thus water used in dialysis was not ro water. It has been reported to mcp the patient was on life support prior to dialysis treatment. Sometime after dialysis treatment (unknown amount of time), the patient was removed from life support and subsequently died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2017-00002 |
| MDR Report Key | 6542253 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-05-03 |
| Date of Report | 2017-05-03 |
| Date of Event | 2017-04-06 |
| Date Mfgr Received | 2017-04-06 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2017-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALEX NELSON |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLENIUM RO SYSTEM |
| Generic Name | WATER PURIFICATION SYSTEMS AND PORTABLE REVERSE OSMOSIS SYSTEMS |
| Product Code | FIP |
| Date Received | 2017-05-03 |
| Model Number | ME14714 |
| 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 AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-05-03 |