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

Model Number M-5491-02

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/16/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a coolflow® irrigation pump and an error message was being displayed.During the procedure, an error was shown on the pump, rebooting the pump and generator did not resolve the issue.Further troubleshooting was performed with no resolution.A hospital close by, was called in order to borrow their coolflow pump; after the equipment was received, the procedure was completed with no patient consequence.Due to this, the case was delayed for 45 minutes.The patient had to be anti-coagulated and was under general anesthesia when this occurred.The physician felt that it could have caused a potential risk to the patient as it was already across the septum with sheaths.Due to this, it was determined for the event to be reportable.

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.Concomitant bwi products: product: stockert 70 rf generator: us catalog # s7001, serial # unknown.Udi # (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a coolflow® irrigation pump and an error message was being displayed.During the procedure, an error was shown on the pump, rebooting the pump and generator did not resolve the issue.Further troubleshooting was performed with no resolution.A hospital close by, was called in order to borrow their coolflow pump; after the equipment was received, the procedure was completed with no patient consequence.Due to this, the case was delayed for 45 minutes.The patient had to be anti-coagulated and was under general anesthesia when this occurred.The physician felt that it could have caused a potential risk to the patient as it was already across the septum with sheaths.Due to this, it was determined for the event to be reportable.The investigational analysis has been completed.The equipment was evaluated and it was found that foot pedal was not seated properly.Reseated foot pedal solved the issue.The device was also subjected to preventive maintenance, safety and functional testing and all tests passed.No malfunction of the cool flow pump.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint was confirmed.Management is notified of failure analysis through the monthly trending meeting.No significant trends have been identified at this time for this device; therefore no capa is requested at this time.

• 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: 4243390
• MDR Text Key: 5011854
• Report Number: 1721752-2014-00013
• 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: 10/16/2014

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: 10/16/2014
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1