MAUDE Adverse Event Report: HEI, INC. COOLFLOW® IRRIGATION PUMP; SIMILAR DEVICE CFP002, PMA # P990071/S5

Model Number M-5491-01

Device Problem Device Remains Activated (1525)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial flutter procedure with a coolflow irrigation pump and experienced problems to deactivate high flow rate when coming off ablation.The system did not display an error message at the time the issue was presented.The procedure was completed by manually changing the flow rate without patient consequence.This event is being reported because inability to deactivate the high flow rate could potentially lead to patient volume overload.

Manufacturer Narrative

Evaluation method - (b)(4)- (actual device tested).Results - (b)(4)- loss of power.Conclusion - (b)(4)- device repaired and returned.(b)(4).It was reported that a patient underwent an atrial flutter procedure with a coolflow® irrigation pump and experienced problems to deactivate high flow rate when coming off ablation.The system did not display an error message at the time the issue was presented.The procedure was completed by manually changing the flow rate without patient consequence.This event is being reported because inability to deactivate the high flow rate could potentially lead to patient volume overload.The investigational analysis has been completed.The device was evaluated and pump did not turn on.Fuses were out of the holder.Checked and reseated internal connections, reseated fuses in the fuse holder fixed the issue.The device was subjected to preventive maintenance (pm), safety and functional testing and all tests passed.No malfunction found on device.The device history record (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 reports.No statistical trends have been identified at this time; therefore, no capa has been requested.

• Brand Name: COOLFLOW® IRRIGATION PUMP
• Type of Device: SIMILAR DEVICE CFP002, PMA # P990071/S5
• 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: 5001047
• MDR Text Key: 24200413
• Report Number: 1721752-2015-00015
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-5491-01
• Device Catalogue Number: CFP001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1