MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-11-10 for AUTOMATED PD SET W/CASSETTE4 PRONG 5C4469C manufactured by Baxter Healthcare - Mountain Home.
[985878]
A customer contacted baxter technical service center regarding a system error code 2240 that occurred on the home choice (hc) during use. The technical service representative (tsr) explained the alarm and advised to start over with new supplies. The spouse stated, the patient line disconnected when the patient rolled over in bed. The nurse was contacted and stated there were no repots of the event from the patient or spouse and that the patient had no injuries related to the event. The hc unit was operational. No patient injury or medical intervention was indicated at the time of the initial report.
Patient Sequence No: 1, Text Type: D, B5
[8133839]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00900 |
| MDR Report Key | 1243206 |
| Report Source | 04 |
| Date Received | 2008-11-10 |
| Date of Report | 2008-10-22 |
| Date of Event | 2008-10-21 |
| Date Mfgr Received | 2008-10-22 |
| Date Added to Maude | 2009-07-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Street | 1900 N HIGHWAY 201 |
| Manufacturer City | MOUNTAIN HOME AR 72653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOMATED PD SET W/CASSETTE4 PRONG |
| Generic Name | 78FKY |
| Product Code | FKY |
| Date Received | 2008-11-10 |
| Catalog Number | 5C4469C |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-10 |