MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-01-15 for SYSTEM 1000 S1000L3 manufactured by Baxter Healthcare - Largo.
[15861139]
A nurse contacted baxter (b)(4) regarding an ultrafiltration issue that occurred with a tina hemodialysis machine, during use, while the patient was connected. The nurse stated that during therapy the machine did not ultrafiltrate the 2. 4 kg as programmed. There was a patient involved, but no patient injury or medical intervention was indicated at the time of the initial report.
Patient Sequence No: 1, Text Type: D, B5
[15946030]
(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
[16604964]
(b)(4). Evaluation: this complaint was confirmed during evaluation of the device and the root cause was determined to be a damaged regulator. A visual inspection was performed with no issues noted. A functional evaluation was performed and a damaged regulator was noted. A device history review was performed with no issues noted. A service history review was performed and a previous service event on (b)(4) 2012 contributed to this reported problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2012-04427 |
| MDR Report Key | 2916799 |
| Report Source | 01,05 |
| Date Received | 2013-01-15 |
| Date of Report | 2012-10-19 |
| Date of Event | 2012-10-19 |
| Date Mfgr Received | 2013-03-05 |
| Date Added to Maude | 2013-04-05 |
| 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 | 2013-01-15 |
| Catalog Number | S1000L3 |
| Operator | NURSE |
| Device Availability | N |
| 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 | 2013-01-15 |