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

Model Number M-5491-02

Device Problems Device Alarm System (1012); Excess Flow or Over-Infusion (1311); Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2016

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.This coolflow pump was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a coolflow pump.The coolflow pump would automatically switch from 2 to 30ml/min when in standby-non radio frequency (rf) mode.The generator was set to "automatic" mode.There were no error messages.The settings were checked, systems rebooted and the cable exchanged but the issue remained.The coolflow pump was replaced.The procedure was continued with no patient consequence.The high flow being delivered with no ablation and no error message was assessed as a reportable malfunction as it is a potential patient injury.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a coolflow pump.The coolflow pump would automatically switch from 2 to 30ml/min when in standby-non radio frequency (rf) mode.The generator was set to ¿automatic¿ mode.There were no error messages.The settings were checked, systems rebooted and the cable exchanged but the issue remained.The coolflow pump was replaced.The procedure was continued with no patient consequence.The device was evaluated and no error was found.Device is within specification.The unit was out of calibration.The device was subjected to pump door replacement, calibration, preventative maintenance, safety and functional testing and all tests passed.No malfunction was found on the device.The device out of calibration does not contribute to automatically switching from the 2 to 30ml/min issue.The device history record (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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6056133
• MDR Text Key: 58711927
• Report Number: 1721752-2016-00010
• 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: 09/30/2016

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-5491-02
• Device Catalogue Number: CFP002
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2008
• Type of Device Usage: Reuse
• Patient Sequence Number: 1