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 2018-08-07 for PLEXITRON TUR IRRIGATION SET ARC4002P manufactured by Baxter Healthcare - Cali.
[116309752]
(b)(6). Should additional relevant information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[116309753]
It was reported the closed device key of an irrigation set continued to flow, while connected to a patient undergoing a surgical procedure, which caused the patient? S bladder to rupture. The adult patient was undergoing kidney transplantation surgery. During the intraoperative period, anuric bladder irrigation was performed in order to distend the bladder. Upon reaching the required safe volume of irrigation, the irrigation process was suspended. The device key (roller clamp) which was connected to the patient? S bladder catheter was closed and left alone with the required bladder volume. At this time, the integrity of the bladder was verified and the steps of the kidney transplantation were continued. Subsequently, a leak of the irrigation solution was observed in the patient? S peritoneal cavity which was immediately followed by bladder rupture. It was reported that the key, which was connected to the patient? S bladder, allowed the irrigation to continue even though it was closed. As a result the pressure of the irrigation fluid caused the patient? S bladder to rupture. No further detail was provided regarding medical intervention or regarding the patient? S outcome from the event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[119723380]
The actual device was not available; however, a video of the sample issue was provided for evaluation and retained samples were evaluated. The video of the sample revealed that the roller clamp was closed and the liquid still flowed through the set. The issue was verified through the video, however, due to the distance and quality of the image, potential damage to the regulatory key could not be identified. Functional testing was performed on the regulatory key of five retention samples and no defects were detected. The retention samples met specification. A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot. A batch review was conducted on the clamp molding which did not identify any nonconformities, failures, rework or deviations that could be associated with the reported issue. A review of the change control records did not identify any changes to specifications, test methods, processes, equipment or (b)(4) materials that could be associated with the reported problem. The reported condition was verified. The cause of the condition could not be determined. A nonconformance has been opened to address this issue.
Patient Sequence No: 1, Text Type: N, H10
[119723381]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-04932 |
| MDR Report Key | 7759241 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-07 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2018-05-09 |
| Date Added to Maude | 2018-08-07 |
| 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 | PHARMACIST |
| 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 - CALI |
| Manufacturer Street | CALLE 36 NO. 2C-22 APARTADO AERO 2446 |
| Manufacturer City | CALI |
| Manufacturer Country | CO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEXITRON TUR IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-08-07 |
| Model Number | NA |
| Catalog Number | ARC4002P |
| Lot Number | SE18ED6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CALI |
| Manufacturer Address | CALI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-07 |