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

Model Number M-5491-01

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

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

Event Date 02/28/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the coolflow pump stopped, all the lights turned on and an error 88 displayed.It came back to 0 flow and the low flow worked well but when they were trying to switch to high flow (by the generator or manually), the pump displayed error 88.They tried to change the power supply cable and disconnected the generator cable, but it did not work.Thirty minutes later, the pump displayed an error 88 continually.It never started correctly from this moment.The procedure had to be stopped.The patient underwent a transseptal puncture and the lasso catheter and the smart touch catheter were in the left atrium but no rf was delivered.When the patient woke up, he was okay.There was no patient injury reported in this procedure.Upon request, additional information was provided on the event.The issue occurred during the procedure while using the pump just before beginning the ablation.There was no patient complication.The outcome for the patient was that the procedure was cancelled after three hours of the patient being under general anesthesia, one groin puncture, one transseptal puncture and the catheters being placed in the left chamber.The physician thought there was a potential risk to the patient due to the procedure being cancelled and rescheduled.The procedure cancellation was only because of the product issue.The patient required extended hospitalization.The procedure being cancelled because of this product issue under the conditions of being under general anesthesia for 3 hours, a transseptal puncture performed, and the patient required extended hospitalization is indicative of a reportable event.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.(b)(4).

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that during an atrial fibrillation (afib) procedure, the coolflow pump stopped, all the lights turned on and an error 88 displayed.It came back to 0 flow and the low flow worked well but when they were trying to switch to high flow (by the generator or manually), the pump displayed error 88.They tried to change the power supply cable and disconnected the generator cable, but it did not work.Thirty minutes later, the pump displayed an error 88 continually.It never started correctly from this moment.The procedure had to be stopped.The patient underwent a transseptal puncture and the lasso catheter and the smart touch catheter were in the left atrium but no rf was delivered.When the patient woke up, he was okay.There was no patient injury reported in this procedure.Upon request, additional information was provided on the event.The outcome for the patient was that the procedure was cancelled after three hours of the patient being under general anesthesia, one groin puncture, one transseptal puncture and the catheters being placed in the left chamber.The patient required extended hospitalization.The error 88 being displayed is a safety feature of the pump that does not allow the device to be used in order to avoid patient injury.The chance of this failure resulting in any patient injury is remote.During repair of the device, assy, driver, stepper_motor; pcbt interface, encoder/counter; pump motor and bumper rubber, latch pump were replaced to address the issue reported.The device was also subjected to preventive maintenance, safety, and functional testing where the device passed all specifications.The device history record (dhr) 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: 3691613
• MDR Text Key: 4244647
• Report Number: 1721752-2014-00005
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P990071/S5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2014

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-5491-01
• Device Catalogue Number: CFP001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 62 YR