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

Model Number M-5491-02

Device Problems Excess Flow or Over-Infusion (1311); Connection Problem (2900); Programming Issue (3014)

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

Event Date 06/11/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a coolflow® irrigation pump and while on the procedure the pump was unable to switch to low flow, it would only stay at high flow settings without an error displaying.At this time ablation was not attempted.The issue was resolved by exchanging the interface cables which were connected to an incorrect port.The procedure was completed without patient consequence.Although it appears to have been user error while setting up the devices, that leaded to the event; this is being reported because the irrigation pump did not switched to low flow rate and this could potentially lead to patient volume overload.

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).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a coolflow® irrigation pump and while on the procedure the pump was unable to switch to low flow, it would only stay at high flow settings without an error displaying.At this time ablation was not attempted.The issue was resolved by exchanging the interface cables which were connected to an incorrect port.The procedure was completed without patient consequence.Although it appears to have been user error while setting up the devices, that leaded to the event; this is being reported because the irrigation pump did not switched to low flow rate and this could potentially lead to patient volume overload.The investigational analysis has been completed.Once cool flow interface cable was seated in the correct port the issue resolved and the system is ready for use.No malfunction of the device.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: COOLFLOW® IRRIGATION PUMP
• Type of Device: PUMP, CIRCULATING-FLUID, LOCALIZED HEAT
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4903482
• MDR Text Key: 6539628
• Report Number: 1721752-2015-00012
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071/S5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

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-5491-02
• Device Catalogue Number: CFP002
• Other Device ID Number: (01)10846835000085
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1