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

Model Number M-5491-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

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.Since the serial number was unknown, the full udi number can not be provided.(b)(4).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a coolflow pump and a stockert 70 system and there was a high flow rate deactivation problem.The coolflow pump was automatically flowing at a high flow rate of 30ml/min in stand-by mode and during ablation.They exchanged the coolflow interface cables and exchanged pumps and the issue persisted.As soon they rebooted the stockert 70 system, the pump displayed ch then began flowing at 30ml/min.They disconnected the interface cable from the back of stockert 70 system and then the pump flowed normally.They switched the generator to the smartablate generator.The procedure was continued with no patient consequence.The issue of the high flow rate not deactivating was assessed as a reportable malfunction since potentially this issue can lead to patient volume overload.This issue is being conservatively reported under both the coolflow pump and the stockert 70 system.

Manufacturer Narrative

The serial number originally reported was unknown.On (b)(6) 2015 the serial number of (b)(4) was provided.(b)(4).

Manufacturer Narrative

Method - actual device not evaluated (b)(4).Results - no results available since no evaluation performed (b)(4).Conclusion - unable to confirm complaint (b)(4).(b)(4).It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a coolflow pump and a stockert 70 system and there was a high flow rate deactivation problem.The coolflow pump was automatically flowing at a high flow rate of 30ml/min in stand-by mode and during ablation.They exchanged the coolflow interface cables and exchanged pumps and the issue persisted.As soon they rebooted the stockert 70 system, the pump displayed ch then began flowing at 30ml/min.They disconnected the interface cable from the back of stockert 70 system and then the pump flowed normally.They switched the generator to the smartablate generator.The procedure was continued with no patient consequence.Repair follow-up was performed and the device will not be shipped for service.Service was declined.Complaint was unable to be confirmed.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 ; 9497893837
• MDR Report Key: 5306368
• MDR Text Key: 34575321
• Report Number: 1721752-2015-00022
• 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,Followup
• Report Date: 11/19/2015

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2016; 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1