MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2012-08-23 for SYSTEM 1000 S1000L3P manufactured by Baxter Healthcare - Largo.
[2928708]
A customer contacted baxter (b)(4) regarding a alarm- blood detected in dialysate that occurred on a tina hemodialysis machine, during dialysis. The home patient (hp) reported the machine was having false "blood leak detected" alarms, the baxter field service engineer (fse) made arrangements to go onsite and evaluate the device. There was patient involvement, but no patient injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
[10032938]
(b)(4). This complaint for an alarm- blood detected in dialysate was confirmed during the on-site device evaluation, and the root cause was determined to be a protein buildup in bld housing. Visual inspection was performed with no observed issues. 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 | 1423500-2012-16477 |
| MDR Report Key | 2711893 |
| Report Source | 01,04 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-08-02 |
| Date Mfgr Received | 2012-08-02 |
| Date Added to Maude | 2012-12-07 |
| 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 | 2012-08-23 |
| Catalog Number | S1000L3P |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-08-23 |