MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-08-07 for SYSTEM 1000 S1000L3P manufactured by Baxter Healthcare - Largo.
[10299103]
(b)(4). This complaint for a ultrafiltration-low report was confirmed during the on-site sample evaluation and the root cause was determined to be due to a damaged ultrafiltration (uf) regulator. The uf regulator was replaced with a new one. A device history was conducted and no issues were found related to the ultrafiltration- low in the logs during the manufacture of the lot or serial number. A service history review was performed with no issues noted.
Patient Sequence No: 1, Text Type: N, H10
[16517189]
(b)(4). No sample was returned for evaluation as the device was evaluated by the field service engineer (fse) at the customer location. A follow-up mdr will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[16580118]
A nurse contacted baxter (b)(4) regarding an ultrafiltration low that happened with a tina hemodialysis machine. The nurse stated that the tina machine did not ultrafiltrate the 3. 3 kilograms that was programmed. There was patient involvement, but no patient injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2012-15628 |
| MDR Report Key | 2684191 |
| Report Source | 01,05 |
| Date Received | 2012-08-07 |
| Date of Report | 2012-07-16 |
| Date of Event | 2012-07-16 |
| Date Mfgr Received | 2012-10-28 |
| Date Added to Maude | 2012-11-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VIRGINIA MCKINNEY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472702835 |
| Manufacturer G1 | BAXTER HEALTHCARE - LARGO |
| Manufacturer Street | 7511 114TH AVE. NORTH |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 1000 |
| Generic Name | SYSTEM, HEMODIALYSIS, ACCESS RECIRCULATION MONITORING |
| Product Code | MQS |
| Date Received | 2012-08-07 |
| Catalog Number | S1000L3P |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - LARGO |
| Manufacturer Address | 7511 114TH AVE. NORTH LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-07 |