MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE manufactured by Baxter Healthcare Corporation.
[185516439]
The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185516440]
A peritoneal dialysis (pd) patient experienced peritonitis. The cause of the peritonitis was reported as due to? Some body infection?. It was reported the patient was hospitalized for the event. The patient was treated with injection of vancomycin (2 gm stat dose, ongoing, frequency and route not reported) and injection of amikacin (500mg, loading dose, ongoing, route and frequency not reported) for the event. For the peritonitis. On an unknown date, pd therapy was discontinued, and the patient was switched to hemodialysis. Ten days after event onset, the patient passed away. The cause of death was reported as due to? Some body infection? Caused by? Inadequate dialysis?. It was not reported if an autopsy was performed. It was reported the patient was not recovering from the peritonitis event at the time of death. It was reported hemodialysis therapy was ongoing at the time of death. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01815 |
| MDR Report Key | 9897700 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | NI NI |
| Manufacturer City | NI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
| Product Code | KDJ |
| Date Received | 2020-03-30 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2020-03-30 |