FDA Adverse Event
Other
Summary report: N
OSMONICS 23G RO SYSTEM
MDR report key: 275077
·
Received April 19, 2000
Report
- Report Number
- 3019131-2000-00005
- Event Type
- Other
- Date Received
- April 19, 2000
- Date of Event
- March 20, 2000
- Report Date
- April 18, 2000
- Manufacturer
- OSMONICS, INC. / MINNETONKA OPERATIONS
- Product Code
- LIP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CHIEF TECHNICIAN AT A DIALYSIS FACILITY IS CONCERNED THAT AN APPARENT FAILURE OF THE PRODUCT DIVERT SYSTEM ON A ROUTINE ORDER COULD CAUSE POSSIBLE CONTAMINATION OF THE PRODUCT STREAM WITH UNPURIFIED WATER. THIS COULD HAVE BEEN CAUSED BY EITHER THE PERMEATE DIVERT SOLENOID OR THE AQUAMATIC VALVE OR BOTH FAILING. THE FEED WATER BEING ON THE HIGHER PRESSURE SIDE OF THE SYSTEM COULD MIGRATE INTO THE PERMEATE MANIFOLD CAUSING THE PERMEATE CONDUCTIVITY TO RISE TO A HIGHER LEVEL TO TDS (TOTAL DISSOLVED SOLIDS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSMONICS 23G RO SYSTEM | WATER PURIFICATION FOR HEMODIALYSIS - RO | LIP | OSMONICS, INC. / MINNETONKA OPERATIONS | HRPA10.5K | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |