MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-30 for RENALOFT RENALSFT manufactured by Baxter Healthcare Corporation.
[400462]
During an observational study for this software a user discovered that, in the patient medications screen, a user can select a medication given to a patien to be documented from a list. But if the enter key is used to select the medication, a separate detail screen may move to the next medication in the list. This may result in the user entering the incorrect medication as given to a patient. A subsequent user review of the medications screen may indicate the original medication was not given to a patient when in fact it was. This may lead to a patient being given a medication a second time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2005-00774 |
| MDR Report Key | 612372 |
| Report Source | 05 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-30 |
| Date of Event | 2005-04-30 |
| Date Mfgr Received | 2005-04-30 |
| Date Added to Maude | 2005-06-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTLE BIELINSKI |
| Manufacturer Street | ROUTE 120 & WILSON ROAD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472706756 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 7511 114TH AVENUE 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 | RENALOFT |
| Generic Name | RENAL THERAPY CLINICAL DATA MANAGEMENT SOFTWARE |
| Product Code | KPF |
| Date Received | 2005-04-30 |
| Model Number | NA |
| Catalog Number | RENALSFT |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 602200 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | RENALOFT |
| Baseline Generic Name | RENAL THERAPY CLINICAL DATA MANAGEMENT SOFTWARE |
| Baseline Model No | NA |
| Baseline Catalog No | RENALSFT |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-30 |