MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-20 for OSMO 23G 23G-HR(PA)4500 * manufactured by Ge Osmonics.
[392851]
Water was being produced by the ro, reverse osmosis, system, but was not able to reach the storage tank and out to the loop. The water level in the storage tank dropped to 70 gallons, which put the system into an automatic shut off mode. In an effort to conserve on water that was not being produced by the ro system, the dialysate flow on all machines was turned down by the staff from 800 cc/min to 500cc/min. This would affect the amount of urea clearance during the patient's normal treatment. The problem turned out to be 2 valves which were replaced. This problem has occurred one other time in the past. Further follow up revealed that the staff were alerted of the problem by the safety alarm on the ro system. The outside company that maintains the system changed the valves and checked the water after the system was repaired. The staff also double checked the water quality to make sure that there were no problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 565185 |
| MDR Report Key | 565185 |
| Date Received | 2004-12-20 |
| Date of Report | 2004-12-16 |
| Date of Event | 2004-12-09 |
| Report Date | 2004-12-16 |
| Date Reported to FDA | 2004-12-20 |
| Date Added to Maude | 2005-01-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSMO 23G |
| Generic Name | REVERSE OSMOSIS PURFICATION MACHINE |
| Product Code | JRS |
| Date Received | 2004-12-20 |
| Model Number | 23G-HR(PA)4500 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 7 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 554957 |
| Manufacturer | GE OSMONICS |
| Manufacturer Address | 7848 SOUTH 202ND ST. KENT WA 98032 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-20 |