MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-07-18 for SYSTEM 1000 S1000L3P manufactured by Baxter Healthcare - Largo.
[3658694]
It was reported that a patient had high ultrafiltration during hemodialysis (hd) therapy. The patient weighed 700 grams less than expected. There was patient involvement, but there was no patient injury or medical intervention indicated at the time of the initial report.
Patient Sequence No: 1, Text Type: D, B5
[10946560]
(b)(4). The device is being evaluated by a field service engineer (fse) at the customer location. Visual inspection was performed, no physical damage was found. The device passed all testing. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[11186631]
(b)(4). The reported condition was not confirmed; the cause was undetermined. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2013-18894 |
| MDR Report Key | 3234931 |
| Report Source | 01,07 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-24 |
| Date of Event | 2013-06-24 |
| Date Mfgr Received | 2013-08-08 |
| Date Added to Maude | 2013-10-09 |
| 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 | CHRISTINA ARNT |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242703198 |
| 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 | 2013-07-18 |
| Catalog Number | S1000L3P |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-07-18 |