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 2019-02-28 for COMPLETE WATER PURIFICATION SYSTEM PVC LOOP manufactured by Mar Cor Purification.
[137508414]
The facility reported a private plumber installed a brass fitting in the water loop of their complete water purification system when splicing the loop together after relocating it. There is potential for brass to leach downstream through the reverse osmosis (ro) pathway, thus potential for patient exposure during hemodialysis treatments. It was reported that the facility ran one day of patient treatments after the brass fitting was installed by the plumber. After the facility's biomed noticed the brass fitting, they reported replacing the brass fitting with a pvc or pex fitting. Ansi/aami 26722:2014 'water treatment equipment for hemodialysis and related therapies' specifically states that brass materials should be avoided due to being documented as being hazardous to the patient. Additionally, if changes are made after installation of the system, the facility is responsible for ensuring appropriate materials/components are used. While the risk to patients derives from long-term cumulative toxicity, mar cor purification has decided to conservatively submit this report due to the potential for patient exposure to brass leaching into the ro pathway. There have been no reports of patient harm. This complaint will continue being monitored in the mar cor purification complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[137508415]
The facility reported a private plumber installed a brass fitting in the water loop of their complete water purification system when splicing the loop together after relocating it. There is potential for brass to leach downstream through the reverse osmosis (ro) pathway, thus potential for patient exposure during hemodialysis treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2019-00003 |
| MDR Report Key | 8380256 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2019-02-28 |
| 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 | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVE N. |
| Manufacturer City | MINNEAPOLIS 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 | COMPLETE WATER PURIFICATION SYSTEM |
| Generic Name | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Product Code | FIP |
| Date Received | 2019-02-28 |
| Model Number | PVC LOOP |
| 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. Other | 2019-02-28 |