MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-12-03 for INTEGRATED APO SET W/CASSETTE3-PRONG 5C4531C manufactured by Baxter Healthcare - Mountain Home.
[1008394]
A customer contacted baxter's technical svc center regarding a system error 2240 alarm that appeared on the home choice (hc) unit during drain 2 of 4. The home pt (hp) became disconnected during therapy. The hp did not reconnect. The technical svc rep (tsr) had the hp cap off the pt line. The hp cycled the power to clear the error 2240. The hp will contact the peritoneal dialysis nurse to advise of the pt line becoming disconnected. The hc was operational. There was no pt injury or medical intervention indicated at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[8150719]
Per the home pt, the sample was discarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00963 |
| MDR Report Key | 1297835 |
| Report Source | 04 |
| Date Received | 2008-12-03 |
| Date of Report | 2008-12-03 |
| Date of Event | 2008-11-06 |
| Date Mfgr Received | 2008-11-06 |
| Date Added to Maude | 2009-11-05 |
| 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 RTE 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 HWY 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 | INTEGRATED APO SET W/CASSETTE3-PRONG |
| Generic Name | 78FKY |
| Product Code | FKY |
| Date Received | 2008-12-03 |
| Catalog Number | 5C4531C |
| Lot Number | UNK |
| 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 | 2008-12-03 |