MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2008-05-13 for AUTOMATED PD SET W/CASSETTE 4 PRONG 5C4469C manufactured by Baxter Healthcare Corporation.
[865958]
A home pt (hp) contacted baxter's tech svc ctr regarding a leaking homechoice (hc) cassette during fill cycle of therapy. Per initial report, baxter's tech svc rep (tsr) assisted the customer during the initial contact. No pt injury or medical intervention was indicated at the time of the initial report. The pt needed to get cassette out. The hp was in fill cycle. The fill volume was 793ml. The hp stated that the pt line started leaking. The tsr assisted hp in ending therapy. Hc ok. This writer called the pt and requested incident details. The pt said that her pet cat was in the room. The cat had chewed on the pt line causing a leak. The pt did mention that she was not connected to the cycler and was in prime cycle of therapy. The nurse was also contacted and made aware of the reason for the leak. The nurse said that the pt was very aware of contamination issues and was very particular about preventing infection. The nurse said that the pt would have contacted them if there was a problem.
Patient Sequence No: 1, Text Type: D, B5
[8081140]
The sample is not required for eval. This incident is due to a use error. There are no further measures to be taken relative to this matter. Renal product surveillance and quality engineering, along with plant manufacturing will continue to monitor this product line and will take corrective/preventative action as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00353 |
| MDR Report Key | 1045422 |
| Report Source | 04,05 |
| Date Received | 2008-05-13 |
| Date of Report | 2008-04-25 |
| Date of Event | 2008-04-25 |
| Date Mfgr Received | 2008-04-28 |
| Date Added to Maude | 2008-07-30 |
| 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 | 25212 W ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 1900 HWY 201 NORTH |
| 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/CASSETTE 4 PRONG |
| Generic Name | CASSETTE/78FKK |
| Product Code | FKK |
| Date Received | 2008-05-13 |
| Catalog Number | 5C4469C |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1041374 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | MOUNTAIN HOME AR 72653 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-13 |