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

Model Number M-5491-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2016

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 procedure with a coolflowirrigation pump and a high flow activation issue occurred.A non mdr reportable error 88 was displayed on the pump during the procedure.Pushing "clr" several times made the error go away and pump could be used manually.However, after some minutes the error reappeared.The cable connection to the stockert was removed, "clr" was pressed and the error disappeared for the rest of the procedure.In addition, the high flow mode did not start automatically with ablation.When this occurred, high flow mode was pressed manually when starting ablation.Throughout the procedure the coolflow pump flow rate needed to be controlled manually, despite being in automatic mode.The procedure was continued without patient consequence using the pump as is.During the flow issue the stockert and coolflow pump did not show any errors and ablation was possible.Therefore this event is mdr reportable because if the ablation is initiated and the irrigation pump does not change to high flow rate it could lead to potential injury to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a coolflow® irrigation pump and a high flow activation issue occurred.A non mdr reportable error 88 was displayed on the pump during the procedure.Pushing ¿clr¿ several times made the error go away and pump could be used manually.However, after some minutes the error reappeared.The cable connection to the stockert was removed, ¿clr¿ was pressed and the error disappeared for the rest of the procedure.In addition, the high flow mode did not start automatically with ablation.When this occurred, high flow mode was pressed manually when starting ablation.Throughout the procedure the coolflow pump flow rate needed to be controlled manually, despite being in automatic mode.The device was evaluated and no error found.The device is within specification.The device was subjected to preventative maintenance, safety and functional testing and all tests passed.No malfunction found on device.The device history record review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: COOLFLOW® IRRIGATION PUMP
• Type of Device: SIMILAR DEVICE CFP002, PMA # P990071/S5
• Manufacturer (Section D): HEI, INC.; 4801 north 63rd. st; boulder CO 80301
• Manufacturer (Section G): HEI, INC.; 4801 north 63rd. st; boulder CO 80301
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5691596
• MDR Text Key: 47530995
• Report Number: 1721752-2016-00007
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/11/2016

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 Model Number: M-5491-01
• Device Catalogue Number: CFP001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1