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 2012-12-07 for SYSTEM 1000 S1000L3 manufactured by Baxter Healthcare - Largo.
[2952846]
A nurse contacted baxter (b)(4) regarding an ultrafiltration- high report with a tina hemodialysis machine, which occurred during therapy while the patient was connected. The nurse stated that the patient was 1. 5 kg lower than the expected weight and the patient experienced low blood pressure and dizziness. However, there was no patient injury and medical intervention was not required as the patient recovered without assistance.
Patient Sequence No: 1, Text Type: D, B5
[10410040]
(b)(4). The device is currently 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
[16426557]
(b)(4). The machine was evaluated and the reported problem was confirmed; the cause was identified as damaged valve of ultrafiltration system. During a visual inspection, it was noted that one of the machines valves was damaged. Due to the damaged valve condition, functional tests were not performed. A device history review and service history review were performed with no issues noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2012-06657 |
| MDR Report Key | 2862290 |
| Report Source | 01,05,07 |
| Date Received | 2012-12-07 |
| Date of Report | 2012-11-14 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2013-03-17 |
| Date Added to Maude | 2013-03-12 |
| 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 | 2012-12-07 |
| 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 | 2012-12-07 |