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

Catalog Number	CFP002
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a coolflow® irrigation pump and ¿air bubbles undetected¿ event occurred.There were no patient consequences.During the procedure, bubbles were not detected.Tubing was flushed and reconnected and the issue persisted.Tubing was changed two (1) times and the issue persisted.Saline was changed and the issue persisted.Pump sensor was wiped and the issue persisted.Ablation catheter (unspecified) was replaced with an ablaze ablation catheter and the issue resolved.Procedure was completed without patient consequences.Tubing was flushed prior to use on the patient.Issue occurred during flushing.There is no information regarding if bubble movement was detected.There is no information regarding if bubbles were detected after passing through the pump sensor.No error codes populated.No alarms sounded.There is no product information for the initial ablation catheter.
Additional Manufacturer Narrative
On 7/30/2018, additional information was received which further confirmed the air bubbles were not visualized in the tubing and the pump did not detect the air bubbles.There is no information available regarding if the pump was in flush mode and no information regarding how changing the ablation catheter solved the issue.Additionally, the following typo was noticed in the initial mdr and should be corrected from, ¿tubing was changed two (1) times and the issue persisted.¿ to ¿tubing was changed two (2) times and the issue persisted.¿ manufacturing ref # (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure with a coolflow® irrigation pump and ¿air bubbles undetected¿ event occurred.There were no patient consequences.During the procedure, bubbles were not detected.Tubing was flushed and reconnected and the issue persisted.Tubing was changed two (1) times and the issue persisted.Saline was changed and the issue persisted.Pump sensor was wiped and the issue persisted.Ablation catheter (unspecified) was replaced with an ablaze ablation catheter and the issue resolved.Procedure was completed without patient consequences.Product evaluation details: the device was evaluated and no error was found.Device is operating within specification.The device was subjected to dc cable replacement as precaution, preventative maintenance, safety and functional testing and all tests passed.No malfunction found on device.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s ref # (b)(4).

• 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: 7699575
• Report Number: 2029046-2018-01805
• Device Sequence Number: 13733193
• 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): 06/22/2018

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: 06/22/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 09/18/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/28/2018; 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1