MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN PUMP, EU CONFIGURATION

Catalog Number D139701

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a pulmonary vein isolation ablation procedure with a ngen pump, eu configuration and an air bubbles undetected issue occurred.During the procedure, bubbles were detected when using the ngen pump, eu configuration; however, no bubble alert detected.No harm to the patient.Flushed the pump to clear the tubing and finished the procedure successfully.The issue was assessed as mdr reportable for air bubbles undetected.

Manufacturer Narrative

Initial reporter phone: (b)(6).The investigation was completed on 12-dec-2022.The bubble sensor was defective, so it was replaced to solve the issue.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).On 26-jun-2023, the product investigation was reopened to correct the h6.Investigation conclusions.Corrected from ¿caused traced to component failure (d02)¿ to ¿cause not established (d15)¿.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).In the 3500a initial the following investigation completion was submitted: the bubble sensor was defective, so it was replaced to solve the issue.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.On 26-jul-2023, the investigation was reopened to perform additional investigation which resulted in the following changes: no failure was found.It was reported that a part was replaced, then they made a correction and changed from "part replaced" to "system replaced" since the system was sent to the repair center.Afterward, it was confirmed that no problem was found on the unit due to the lab was unable to reproduce the reported problem.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.Therefore, updated the following codes: -h6.Component code removed "bubble sensor (g0301201)".-h6.Investigation findings from operational problem identified (c13) to no device problem found (c19).-h6.Investigation conclusions from ¿cause not established (d15) to no problem detected (d14).In addition, noted a correction to the manufactured date.Therefore, processed the h4.Device manufacture date from 28-jun-2022 to 18-may-2022.

• Brand Name: NGEN PUMP, EU CONFIGURATION
• Type of Device: NGEN PUMP
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER, INC.; 560 cottonwood drive; milpitas CA
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16028094
• MDR Text Key: 308475149
• Report Number: 2029046-2022-03220
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990071/S037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND TUBING