MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2004-04-27 for RENAL LINK MULTI-USER BASE 5 LICENSE 5M5591 manufactured by Baxter Healthcare Corporation.
[344421]
A dialysis facility coordinator reported an anomaly in the renal link software product. It was discovered that if an existing medication name is changed in the "maintenance-medication" window, the software makes the same change for all pts listed in the system for that medication and the user is not informed that this has occurred. It was reported that there was no indication that incorrect medications were administered and there have been no adverse events as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2004-00364 |
| MDR Report Key | 552379 |
| Report Source | 01,07 |
| Date Received | 2004-04-27 |
| Date of Report | 2004-03-19 |
| Date of Event | 2003-10-01 |
| Date Mfgr Received | 2004-03-19 |
| Date Added to Maude | 2004-11-01 |
| 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 | RENAL LINK MULTI-USER BASE 5 LICENSE |
| Generic Name | RENAL LINK |
| Product Code | KPF |
| Date Received | 2004-04-27 |
| Model Number | NA |
| Catalog Number | 5M5591 |
| 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 | 541930 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 7511 114TH AVE NORTH LARGO FL 33773 US |
| Baseline Brand Name | RENAL LINK MULTI-USER |
| Baseline Generic Name | RENAL LINK |
| Baseline Model No | NA |
| Baseline Catalog No | 5M5591 |
| 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 | 2004-04-27 |