MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2012-11-01 for SYSTEM 1000 S1000L3P manufactured by Baxter Healthcare - Largo.
[3021855]
A customer contacted baxter (b)(4) regarding a burnt odor coming from a tina hemodialysis machine, during citric heat clean, while the home patient (hp) was not connected. There was no patient injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[10282932]
(b)(4). This complaint for a report of "burnt odor" was confirmed and the root cause was determined to be due to a blockage of air inlet because of dust accumulation. No sample was returned for evaluation as the device was evaluated by the field service engineer (fse) at the customer location. During the evaluation, the reported condition of: "smelling burning smell" was confirmed but not duplicated by the fse. Visual inspection was performed and no issues were observed. As part of corrective action for reported problem; the fse cleared all of the dust in the fan input grills (internal filter was checked and was found to be clean) and performed self test. The device was evaluated and all necessary functional tests were performed and passed as per baxter? S standard operating policies and procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2012-03218 |
| MDR Report Key | 2814191 |
| Report Source | 01,04 |
| Date Received | 2012-11-01 |
| Date of Report | 2012-10-04 |
| Date of Event | 2012-10-04 |
| Date Mfgr Received | 2012-10-04 |
| Date Added to Maude | 2013-02-06 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 2012-11-01 |
| Catalog Number | S1000L3P |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-11-01 |