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

Model Number M-5491-02

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2016

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.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a coolflow® irrigation pump and undetected air bubbles occurred.A bubble error would display after the bubbles passed the pump.No troubleshooting could be performed; the case was completed successfully with no patient consequence.Upon request additional information was received on the event.The customer flushed the tubing before using it on the patient.The air bubbles were detected after passing through the pump sensor.There was a bubble error on the pump, however, the issue was that several bubbles had already passed through the sensor and were between the pump and the patient.This is indicative of a reportable event because if the bubble sensor failed to detect the air bubbles, it could lead to potential patient harm.

Manufacturer Narrative

Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes (evaluation codes) will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).It was reported that a patient underwent a procedure with a coolflow® irrigation pump and undetected air bubbles occurred.Repair follow up was performed and service was declined.The device history record was performed and device was within specification.

• 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: 5442730
• MDR Text Key: 39091560
• Report Number: 1721752-2016-00002
• 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: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• 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: SEE H10.
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1