MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-01-09 for SYSTEM 1000 S1000L3 manufactured by Baxter Healthcare - Largo.
[3062279]
A nurse contacted baxter (b)(4) regarding an incident of an ultrafiltration issue on a tina hemodialysis machine, during use. The nurse stated that the patient had a loss of 1. 5kg after treatment and the machine was programmed with 2. 5kg. There was patient involvement. There was no patient injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
[10350044]
(b)(4). The device is in the process of being evaluated by the baxter field service engineer (fse) at the customer location. A follow-up mdr will be submitted upon the completion of the evaluation or if any additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[10642665]
(b)(4). Initial evaluation confirmed the reported condition. Upon completion of baxter's investigation, a follow-up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[15417172]
(b)(4). The sample was evaluated by baxter. A visual inspection was performed with no issues noted. Functional tests were performed and the restricted flow was confirmed, due to a diener pump failure. The faulty pump was changed, and the new dienier pump passed all tests. A device history log review and service history review were performed with no issues noted. The sample was confirmed for the reported problem; and the root cause was determined to be a faulty dienier pump.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2013-00601 |
| MDR Report Key | 2903859 |
| Report Source | 01,05,07 |
| Date Received | 2013-01-09 |
| Date of Report | 2012-12-18 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2013-05-20 |
| Date Added to Maude | 2013-04-01 |
| 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 | 2013-01-09 |
| Catalog Number | S1000L3 |
| 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 | 2013-01-09 |