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

Model Number M-5491-02

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 09/02/2014

Event Type  malfunction  

Event Description

It was reported that a patient, underwent an atrial fibrillation procedure with a coolflow® irrigation pump and noise on all intracardiac and body surface electrocardiograms was being displayed on carto 3 and recording system; however when coolflow pump was replaced the issue resolved.There was no patient consequence.This event is being reported because this issue could potentially contribute to a serious injury.

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).Evaluation summary: (b)(4).It was reported that a patient, underwent an atrial fibrillation procedure with a coolflow® irrigation pump and noise on all intracardiac and body surface electrocardiograms was being displayed on carto 3 and recording system.The cool flow pump was replaced and the issue resolved.At the moment the complaint was received this was an indication that the cool flow pump was causing the noise experienced by the customer.Therefore, the complaint was reported under cool flow pump.However, as the investigational analysis has been completed and device was fully inspected it was not possible to reproduce the failure mode; therefore the origin of this issue remains unknown and customer complaint could not be verified.In addition, it was confirmed that the patient¿s heart rhythm was able to be monitored through an ecg visible signal on hospital equipment.Since the physician was able to monitor the patient¿s heart rhythm, patient safety was not at risk.This complaint was reassessed as not reportable.

• 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: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4141115
• MDR Text Key: 17573823
• Report Number: 1721752-2014-00010
• 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: 09/03/2014

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: 09/03/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1