MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-08 for HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG 5C4531 manufactured by Baxter Healthcare.
[512919]
A home pt (hp) contacted baxter's technical svc ctr regarding a system error 2240 that appeared on the display of their homechoice machine during intial drain. Per initial report, the home pt disconnected/ reconnected their transfer set from the pt line during therapy. The baxter technical svc rep instructed the home pt to recycle power, discard used supplies, and start therapy over using new supplies. During a follow up phone call regarding the initial 2240 alarm, a baxter product surveillance specialist was notified by the home pts peritoneal dialysis (pd) nurse that the home pt was treated for perionitis (diagnosis date unk) and was discharged from the hosp in 2006. The home pt has made a full recovery and is scheduled to visit their pd in five days. The pd nurse does not have access to lab results, diagnosis comments, or treatment notes. The hp's nurse will attempt to obtain the hard copy of the hp's discharge papers / medical record from the admitting hosp and fax the info to baxter's product surveillance by 09/13/2006. No further info is available at this time; an ongoing investigation is in progress.
Patient Sequence No: 1, Text Type: D, B5
[7794419]
Baxter's product surveillance dept is pursuing additional info regarding this report. A follow up report will be submitted if additional info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2006-01003 |
| MDR Report Key | 764428 |
| Report Source | 05 |
| Date Received | 2006-09-08 |
| Date of Report | 2006-09-08 |
| Date of Event | 2006-08-21 |
| Date Mfgr Received | 2006-09-08 |
| Date Added to Maude | 2006-09-27 |
| 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 | KAREN KIRBY, MGR |
| Manufacturer Street | ROUTE 120 & WILSON RD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE CORP |
| Manufacturer Street | 1900 HIGHWAY, 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653249 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 2497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG |
| Generic Name | APD DISPOSABLES HOMECHOICE |
| Product Code | FKY |
| Date Received | 2006-09-08 |
| Model Number | NA |
| Catalog Number | 5C4531 |
| Lot Number | NA01 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 752284 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | * MOUNTAIN HOME AR * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-09-08 |