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

Model Number M-5491-02

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

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

Event Date 10/30/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a coolflow® irrigation pump and experienced several issues regarding bubbles, as there was an error bubble shown when there were no bubbles seen and when bubbles were seen they went through the pump without the pump detecting them.Per 21 cfr, part 803, this complaint is reportable because if bubble sensor failed to detect the air bubbles it could lead to air embolism.

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

Evaluation summary: (b)(4).It was reported that a patient underwent a procedure with a coolflow® irrigation pump and air bubble alarm is sounding when there are no bubbles in the coolflow tubing.Also the air bubble alarm is not sounding when there are bubbles in the coolflow tubing.The investigational analysis has been completed.The device was evaluated and no error found.Device is within specification.The device was subjected to pm, safety and functional testing and all tests passed.No malfunction found on device.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.

• 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: 4282056
• MDR Text Key: 5032463
• Report Number: 1721752-2014-00014
• 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: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• 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
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1