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

Catalog Number CFP001

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation results: the device was evaluated, and was found to be within specification.No errors were found.Preventative maintenance, safety and functional tests were performed, and all tests passed without issue.A device history record (dhr) review was performed, and it verified that the device was manufactured in accordance with documented specification and procedures.The customer complaint could not be confirmed.(b)(4).

Event Description

It was reported that a patient underwent a procedure for paroxysmal atrial fibrillation with a coolflow irrigation pump where the flow rate would increase from 2 ml to 60 ml on its own.During the procedure, the issue with the flow rate increasing was noted.A spare pump was used to complete the procedure.No patient consequences were reported.It is not known if an error message populated or not.Multiple attempts were made to obtain additional information regarding this complaint, but none was made available.If there is no error message when the irrigation pump is delivering high flow during periods of no ablation, there is a potential risk to the patient.As a result, this event is mdr reportable.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 6996386
• MDR Text Key: 91949603
• Report Number: 2029046-2017-01082
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial

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: 10/05/2017
• Initial Date FDA Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1