MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-04-19 for OSMONICS 23G RO SYSTEM HRPA10.5K * manufactured by Osmonics, Inc. / Minnetonka Operations.
[171406]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2000-00005 |
| MDR Report Key | 275077 |
| Report Source | 05,06 |
| Date Received | 2000-04-19 |
| Date of Report | 2000-04-18 |
| Date of Event | 2000-03-20 |
| Date Mfgr Received | 2000-03-20 |
| Device Manufacturer Date | 1994-07-01 |
| Date Added to Maude | 2000-04-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICK LYNCH |
| Manufacturer Street | 7848 SOUTH 202ND ST |
| Manufacturer City | KENT WA 98032 |
| Manufacturer Country | US |
| Manufacturer Postal | 98032 |
| Manufacturer Phone | 2533952200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSMONICS 23G RO SYSTEM |
| Generic Name | WATER PURIFICATION FOR HEMODIALYSIS - RO |
| Product Code | LIP |
| Date Received | 2000-04-19 |
| Model Number | HRPA10.5K |
| Catalog Number | * |
| Lot Number | * |
| ID Number | CR 0003058 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 266247 |
| Manufacturer | OSMONICS, INC. / MINNETONKA OPERATIONS |
| Manufacturer Address | 5951 CLEARWATER DR MINNETONKA MN 55343 US |
| Baseline Brand Name | OSMONICS 23G RO SYSTEM |
| Baseline Generic Name | WATER PURIFICATION FOR HEMODIALYSIS - RO |
| Baseline Model No | HRPA10.5K |
| Baseline Catalog No | * |
| Baseline ID | CR 0003058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-04-19 |