MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI PLEXITRON TUR IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number ARC4002P

Device Problem Improper Flow or Infusion (2954)

Patient Problems Rupture (2208); Abdominal Distention (2601)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information becomes available, a supplemental report will be submitted.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: PLEXITRON TUR IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE - CALI; cali
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; calle 36 no. 2c-22; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7759241
• MDR Text Key: 116309752
• Report Number: 1416980-2018-04932
• Device Sequence Number: 1
• Product Code: LJH
• UDI-Device Identifier: 00085412479460
• UDI-Public: (01)00085412479460
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: ARC4002P
• Device Lot Number: SE18ED6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: IRRIGATION FLUID (UNSPECIFIED)
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 54