MAUDE Adverse Event Report: BIOSENSE WEBSTER INC COOLFLOW® IRRIGATION PUMP; SIMILAR DEVICE CFP002, PMA # P990071/S5

Catalog Number CFP001

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

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 # (b)(4).

Event Description

It was reported that a patient underwent paroxysmal atrial fibrillation (afib) ablation procedure with a coolflow® irrigation pump and it was reported that the loaner coolflow® irrigation pump and a high flow rate deactivation problem occurred.It was reported that during the procedure, the coolflow® irrigation pump would freeze when trying to change the catheter flow.It was notes that it would not automatically deactivate the high flow from 17 ml to 2 ml after stopping the ablation.When changing manually it did change to 2 ml but then automatically went down to 0.Due to the harm this could cause, a nurse had to stand next to the pump to control it and change quickly.There was no patient consequence.No other information has been provided.The issue of high flow rate deactivation problem is considered an mdr reportable malfunction.

Manufacturer Narrative

Investigation summary.It was reported that a patient underwent paroxysmal atrial fibrillation (afib) ablation procedure with a coolflow® irrigation pump and it was reported that the loaner coolflow® irrigation pump and a high flow rate deactivation problem occurred.It was reported that during the procedure, the coolflow® irrigation pump would freeze when trying to change the catheter flow.It was notes that it would not automatically deactivate the high flow from 17 ml to 2 ml after stopping the ablation.When changing manually it did change to 2 ml but then automatically went down to 0.There was no patient consequence.The device was evaluated, and no error was found.The device was performing within specification.The device was also subjected to preventative maintenance (pm), and safety and functional testing.All tests passed and there was no device malfunction found.The customer complaint was not confirmed.The device history record (dhr) was reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's reference # (b)(4).

• Brand Name: COOLFLOW® IRRIGATION PUMP
• Type of Device: SIMILAR DEVICE CFP002, PMA # P990071/S5
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9514230
• MDR Text Key: 200652732
• Report Number: 2029046-2019-04065
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CFP001
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1