MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-21 for RENAL SOFTWARE SUITE UPGRADE 5M5603 manufactured by Baxter Healthcare Corporation.
[17033740]
On 06/22/05, the customer called the baxter customer service center to report a problem with the arena device, renal software and patient data cards. He stated that he reprogrammed all of the pt data cards to a standard bath (bicarb solution) of 39. He took the card and put it into the arena and the prescription read 42 instead of 39. He then removed the card and checked it in renal soft and the prescription read 39 as programmed. He also tried soft and the prescription read 39 as programmed. He also tried another card and that card read 34 instead of the programmed 39.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2005-01048 |
| MDR Report Key | 720124 |
| Report Source | 05 |
| Date Received | 2005-07-21 |
| Date of Report | 2005-07-12 |
| Date of Event | 2005-06-22 |
| Date Mfgr Received | 2005-06-22 |
| Date Added to Maude | 2006-05-31 |
| 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, MGR |
| Manufacturer Street | ROUTE 120 & WILSON RD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472706756 |
| Manufacturer G1 | BAXTER HEALTHCARE CORP |
| 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 | RENAL SOFTWARE SUITE UPGRADE |
| Generic Name | RENAL THERAPY CLINICAL DATA MANAGEMENT SOFTWARE |
| Product Code | KPF |
| Date Received | 2005-07-21 |
| Returned To Mfg | 2005-07-18 |
| Model Number | NA |
| Catalog Number | 5M5603 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 709193 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | * LARGO FL * 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 | 2005-07-21 |