MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-25 for SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE manufactured by Baxter Healthcare Corporation.
[185043960]
Event was reported to have occurred on an unreported date in (b)(6) 2019. This report is for a breach in aseptic technique which resulted in peritonitis. Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy. A review of the label for the product family will be conducted. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185043961]
It was reported a peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis. The breach in aseptic technique was further described as due to improper operations. It was not reported if the patient was hospitalized for the event. On an unreported date, the patient was treated with vancomycin and other "unspecified imported drugs" (doses, routes, frequencies and durations were not reported) for peritonitis. At the time of this report, the patient was recovered from the event. Pd therapy was continued at the earlier stage of treatment and was withdrawn at the later stage of the treatment. It was not reported if the patient was retrained on the proper aseptic technique. No additional information could be provided as the reporter declined follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01708 |
| MDR Report Key | 9878677 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-25 |
| 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 | 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 | 2020-03-25 |
| 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. Required No Informationntervention | 2020-03-25 |