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

Model Number M-5491-01

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/27/2014

Event Type  malfunction  

Event Description

It was reported that during this procedure there were two issues.First issue, there was a hardware error 9 during a pulmonary vein isolation (pvi).There was no patient injury reported in this procedure.Upon request, additional information was provided on this issue.The procedure was continued with a different generator.This issue was not indicative of a reportable event.Second issue, the coolflow pump dropped from 30ml to 0ml twice during the procedure.Upon request, additional information was provided on this issue.There was no error/warning message on the coolflow pump when the coolflow pump dropped from 30ml to 0 ml.Since there was no error/warning message when the pump was delivering low flow, this issue is indicative of a reportable event.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.Concomitant product: ep - shuttle rf generator system - 100w, mfg #: 39d-76x, serial #: (b)(4).

Manufacturer Narrative

It was initially reported in the 3500a report that the coolflow pump dropped from 30ml to 0ml twice during the procedure.Upon request, additional information was provided on this issue.There was no error/warning message on the coolflow pump when the coolflow pump dropped from 30ml to 0 ml.Since there was no error/warning message when the pump was delivering low flow, this issue was indicative of a reportable event.Additional clarification on the event was received on april 30, 2014 stating that the generator could not be used when the pump dropped to zero.Also the generator was alarming an error 9 during this time.Therefore, since the generator could not be used when the pump dropped to zero and there was also an error populating, this makes this event highly detectable thus this malfunction is not indicative of a reportable event.Evaluation summary: (b)(4).It was reported that the coolflow pump dropped from 30ml to 0ml twice during the procedure.The stockert generator interfaced with the pump presented hardware error 9 ending the ablation delivery.This is a safety feature of the pump that does not allow the generator to be used in order to avoid patient injury.The ifu indicates the user to stop using the generator upon an error.The issue was resolved by reconnecting the loose interface cable between the generator and the pump.The chance of this error resulting in any patient injury is remote.The issue could not be duplicated in other cases and also performs to specification when connected to another generator.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: 3627192
• MDR Text Key: 4185261
• Report Number: 1721752-2014-00003
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P990071/S5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2014

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: 01/25/2014
• Initial Date FDA Received: 02/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1