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

Catalog Number D139701

Device Problem Decreased Pump Speed (1500)

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

Event Date 01/19/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation with a ngen pump, eu configuration and the flow rate is not correct on the pump.During the procedure, the ngen pump did not work properly.The physician noticed that the temperature of the catheter is higher with this pump than with any other pump.The physician thinks that the flow rate is not correct as it was not giving the ¿right amount of ml/per minute¿.Compared with another ngen pump, did not have temperature issue on the other one.The temperature goes up really fast.There was no patient consequence.

Manufacturer Narrative

Initial reporter phone: (b)(6).The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation with a ngen pump, eu configuration and the flow rate is not correct on the pump.During the procedure, the ngen pump did not work properly.The physician noticed that the temperature of the catheter is higher with this pump than with any other pump.The physician thinks that the flow rate is not correct as it was not giving the ¿right amount of ml/per minute¿.Compared with another ngen pump, did not have temperature issue on the other one.The temperature goes up really fast.There was no patient consequence.Device evaluation details: the bwi field service engineer (fse) detected that the pump speed was incorrect.The unit was replaced to resolve the issue.A device history record (dhr) evaluation was performed for the finished device [082820-101] number, and no internal actions related to the reported complaint condition were identified.Based on the dhr, the h 4.Device manufacture date has been updated.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13524895
• MDR Text Key: 289007119
• Report Number: 2029046-2022-00296
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P990071/S037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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