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

Catalog Number CFP001

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

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.(b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a coolflow® irrigation pump.It was reported that the high flow and low flow rates were not functioning properly during surgery.There was only slow water at the flow rate of 60ml/min.There was no patient consequence reported.Response received confirmed that the coolflow® irrigation pump didn¿t change to high flow when the ablation was initiated.It was also confirmed that the system didn¿t display any error/warning message.They tried manual and automatic mode.They also tried power and temperature control mode.Since the ablation was initiated and the coolflow® irrigation pump did not change to high flow rate, this event was assessed as a reportable malfunction under the coolflow® irrigation pump.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a coolflow® irrigation pump.It was reported that the high flow and low flow rates were not functioning properly during surgery.There was only slow water at the flow rate of 60ml/min.There was no patient consequence reported.Response received confirmed that the coolflow® irrigation pump didn¿t change to high flow when the ablation was initiated.It was also confirmed that the system didn¿t display any error/warning message.They tried manual and automatic mode.They also tried power and temperature control mode.The device was evaluated and encoder optical was defective.Defective part was replaced.Issue was resolved.The device was also subjected to a preventative maintenance, safety and functional testing and all tests passed.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's reference number: (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: 7292537
• MDR Text Key: 101146105
• Report Number: 2029046-2018-01165
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

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: 11/02/2017
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1