MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-05-27 for SYSTEM 1000 S1000L3P manufactured by Baxter Healthcare - Largo.
[2113489]
On (b)(6) 2010, baxter's (b)(4) technical services (cts) received a telephone call in which a customer reported an issue with one tina single pump. The customer reported that the device was giving numerous false "blood leak detected" messages. A baxter field services representative made arrangements to go onsite to investigate the device. As such, the device will not be returned to cts for eval. It is unk during what process the event occurred. There was no reported pt injury or medical intervention. Incident date: (b)(6) 2010. Baxter notification date: (b)(6) 2010. Product surveillance notification date: (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
[9197659]
(b)(4). This mdr is being submitted as part of retrospective summary report (b)(4). (b)(4). These reports are being filed late to fulfill baxter's commitment to perform a two year retrospective review of renal complaints in response to (b)(4) the actual device was evaluated and the reported condition of false blood leak alarms were confirmed. The root cause of the reported condition was determined to be that there was a leak in the blood leak detector. The blood leak detector was replaced to fix the reported condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-06549 |
| MDR Report Key | 2149487 |
| Report Source | 01,04 |
| Date Received | 2011-05-27 |
| Date of Report | 2010-07-02 |
| Date of Event | 2010-07-02 |
| Date Mfgr Received | 2010-07-02 |
| Date Added to Maude | 2011-11-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DI |
| Product Code | FKP |
| Date Received | 2011-05-27 |
| Model Number | NA |
| Catalog Number | S1000L3P |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - LARGO |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-27 |