MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-04-13 for SOFTWARE UPGRADE 5M5603 manufactured by Baxter Healthcare Corporation.
[19781941]
A dialysis facility nurse reported an anomaly with the renalsoft software product. It was discovered that when attempting to create a new medication record from an existing medication record in the prescription screen for an individual pt by using the "copy from" button, the software will intermittently copy the medication record in the first row instead of the intended row, when the medication to be copied has a stop date in the future, and the medication in the first row does not have a stop date. It was reported that the issue was immediately discovered and corrected and no pts were affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2004-00365 |
| MDR Report Key | 550444 |
| Report Source | 05 |
| Date Received | 2004-04-13 |
| Date of Report | 2004-03-19 |
| Date of Event | 2004-01-16 |
| Date Mfgr Received | 2004-03-19 |
| Date Added to Maude | 2004-10-25 |
| 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 | CHRISTIANA BIELINSKI, MANAGER |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1423500-4/8/04-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFTWARE UPGRADE |
| Generic Name | RENAL LINK |
| Product Code | KPF |
| Date Received | 2004-04-13 |
| Model Number | NA |
| Catalog Number | 5M5603 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 539972 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 7511 114TH AVENUE NORTH LARGO FL 33773 US |
| Baseline Brand Name | SOFTWARE UPGRADE |
| Baseline Generic Name | RENAL LINK |
| Baseline Model No | NA |
| Baseline Catalog No | 5M5603 |
| Baseline ID | NA |
| Baseline Device Family | RENAL THERAPY CLINICAL DATA MGMT SOFTWARE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K990953 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-04-13 |