MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-01-16 for SYSTEM 1000 SPDS manufactured by Baxter Healthcare Corporation.
[20765383]
In 2005, the facility reported to baxter customer services that a system 1000 hemodialysis instrument had high bacteria counts. This was discovered during bio-med testing, before a pt was connected to the device. No pt injury or medical intervention was reported in association to this incident. A baxter field svc engineer went to the facility to evaluate the instrument in 2005. The baxter rep found a leak at the female bleach fitting. Replaced the female bleach fitting and the blue dialyzer connector. A svc call report was completed and all systems functioned per manufacturer's specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2006-00092 |
| MDR Report Key | 667364 |
| Report Source | 05,07 |
| Date Received | 2006-01-16 |
| Date of Report | 2005-12-27 |
| Date of Event | 2005-12-01 |
| Date Mfgr Received | 2005-12-27 |
| Date Added to Maude | 2006-01-26 |
| 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 | 0 |
| Manufacturer Contact | CHRISTIANA BIELINSKI, MANAGER |
| Manufacturer Street | ROUTE 120 & WILSON ROAD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472706756 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 14620 NW 60TH AVE |
| Manufacturer City | MIAMI LAKE FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 1000 SPDS |
| Generic Name | SYSTEM 1000 |
| Product Code | KPF |
| Date Received | 2006-01-16 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 656722 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | * MIAMI LAKES FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-01-16 |