MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2005-12-23 for HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG MRM4469 manufactured by Baxter Healthcare Corporation.
[416509]
Baxter reported a cracked cassette found during the priming cycle. No pt injury or medical intervention was indicated at the time of the initial report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2005-02088 |
| MDR Report Key | 656844 |
| Report Source | 01,04,07 |
| Date Received | 2005-12-23 |
| Date of Report | 2005-12-01 |
| Date of Event | 2005-11-01 |
| Date Mfgr Received | 2005-12-01 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2005-12-29 |
| 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 | WENDY KOLLROSS, MANAGER |
| Manufacturer Street | ROUTE 120 & WILSON ROAD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704650 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | CALLE 36 NO. 2C-22 |
| Manufacturer City | CALI |
| Manufacturer Country | CO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG |
| Generic Name | HOMECHOICE CASSETTE |
| Product Code | FKK |
| Date Received | 2005-12-23 |
| Model Number | NA |
| Catalog Number | MRM4469 |
| Lot Number | SE05EM4 |
| ID Number | NA |
| Device Expiration Date | 2009-05-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 646329 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | * CALI CO |
| Baseline Brand Name | HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG |
| Baseline Generic Name | HOMECHOICE CASSETTE |
| Baseline Model No | NA |
| Baseline Catalog No | MRM4469 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-23 |