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 2019-04-01 for 23G SERIES REVERSE OSMOSIS SYSTEM manufactured by Mar Cor Purification.
[140549334]
The facility reported 6-8 patients becoming sick during dialysis treatment using the 23g reverse osmosis water purification system. All patient treatments were discontinued and one patient sought medical attention after presenting symptoms of dizziness and cramps. In communication with mar cor purification field service technician, the facility's nurse manager reported high chlorine levels were detected in the product water at the end of the loop (post ro system). Mar cor purification field service technician visited the facility the following day and performed a complete check of the water room equipment. Chlorine tests were performed on primary and secondary carbon filters as well as the end of the loop. All results showed the system was operating within specification. Mar cor purification regulatory followed up with the facility's nurse manager and it was confirmed that the system was operating normally and there have been no issues since the reported incident. The cause of the patients becoming sick has not been determined. The nurse manager confirmed all the patients are doing fine and are continuing treatment. Mar cor purification has received no similar complaints, indicating this is an isolated, site-specific incident. This complaint will continue being monitored in the mar cor purification complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[140549335]
The facility reported 6-8 patients becoming sick during dialysis treatment using the 23g reverse osmosis water purification system. All patient treatments were discontinued and one patient sought medical attention after presenting symptoms of dizziness and cramps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2019-00005 |
| MDR Report Key | 8471404 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-09 |
| Date Mfgr Received | 2019-03-09 |
| Date Added to Maude | 2019-04-01 |
| 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 | 23G SERIES REVERSE OSMOSIS SYSTEM |
| Generic Name | WATER PURIFICATION SYSTEM |
| Product Code | FIP |
| Date Received | 2019-04-01 |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2019-04-01 |