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 2020-03-31 for SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE manufactured by Baxter Healthcare Corporation.
[185721533]
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
[185721574]
A peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis that was manifested by abdominal pain. The breach in aseptic technique was described as patient made an unspecified mistake. The patient was hospitalized one day after the event onset. On an unreported date, the patient was treated with vancomycin injection (1g, intraperitoneal, once in 4 days, duration not reported), fortum injection (1g, intraperitoneal, once a day, duration not reported), amikacin injection (125mg, intraperitoneal, once a day, duration not reported), imepenem injection (250mg, intraperitoneal, frequency and duration were not reported) and cifran injection (intraperitoneal, dose, frequency and duration were not reported) for the event. On an unreported date, vancomycin and fortum injection were discontinued. Amikacin, imepenem and cifran injections were ongoing. Four days after the event onset, the patient was recovered and was discharged the following day. Pd therapy was ongoing. It was reported that the patient has been retrained for proper aseptic technique. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01861 |
| MDR Report Key | 9903335 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| 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 | 2020-03-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |