MAUDE Adverse Event Report: BIOSENSE WEBSTER INC COOLFLOW® IRRIGATION PUMP; PUMP, CIRCULATING-FLUID, LOCALIZED HEAT

Catalog Number	CFP002
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional 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.This coolflow® irrigation pump was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Concomitant product: non biosense webster, inc.- st.Jude medical generator.The event date is reflecting as (b)(6) 2018.However, the alert date is reflecting as (b)(6) 2018.The dates are displaying different due to time zone differences as this event is from (b)(6).(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow® irrigation pump.It was noted that the flow rate was low when first flushing was conducted.They described the issue as instead of flowing like a shower, it was a cloudy flow.The issue improved a little by rebooting the system and the procedure was continued.No patient consequences were reported.After the procedure, when flushing was conducted again, it was stated that there was a time lag of several seconds.Additional information was received on the event.The response received confirmed that no error/warning message was displayed on the system.It also confirmed that the system allowed the ablation when the issue occurred.Since there was no error/warning message when the irrigation pump was delivering low flow during the ablation, this event was assessed as a reportable malfunction.
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow® irrigation pump.It was noted that the flow rate was low when first flushing was conducted.They described the issue as instead of flowing like a shower, it was a cloudy flow.The issue improved a little by rebooting the system and the procedure was continued.No patient consequences were reported.After the procedure, when flushing was conducted again, it was stated that there was a time lag of several seconds.Additional information was received on the event.The response received confirmed that no error/warning message was displayed on the system.It also confirmed that the system allowed the ablation when the issue occurred.The device was evaluated and no error was found.Device is within specification.The device was subjected to a preventative maintenance, safety and functional testing and all tests passed.No malfunction found on device.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Additional Manufacturer Narrative
The device history record (dhr) review was provided on may 29, 2018.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: COOLFLOW® IRRIGATION PUMP
• Common Device Name: PUMP, CIRCULATING-FLUID, LOCALIZED HEAT
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7333228
• Report Number: 2029046-2018-01319
• Device Sequence Number: 23
• Product Code: DRF
• UDI-Device Identifier: 10846835000085
• UDI-Public: 10846835000085
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P990071/S5
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: CFP002
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018; 02/14/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 06/01/2018; 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1