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

Model Number M-5491-01

Device Problems Inaccurate Flow Rate (1249); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

It was reported that errors 88, ch and 12 were displayed during this procedure.Also when trying to ablate in thermocool mode, the coolflow pump only stayed in low velocity.The high flow had to be activated manually.They tried the same cable with another coolflow pump and it worked normally.There was no patient injury reported in this procedure.Clarification was received on the event.The ablation had initiated and the coolflow pump did not change to high flow.The ablation being initiated with the pump not changing to high flow rate 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

It was initially reported in the 3500a report that the ablation had initiated and the coolflow pump did not change to high flow.The ablation being initiated with the pump not changing to high flow rate is indicative of a reportable event.Additional clarification on the event has been provided on march 24, 2014.There was no ablation delivered with low flow.The stockert generator stopped the ablation and the "check low flow" error populated.The generator functioned as intended.The ablation not starting and the error populating makes this event highly detectable thus this malfunction is not indicative of a reportable event.Evaluation summary: (b)(4).It was reported that errors 88, ch and 12 were displayed during this procedure.Also when trying to ablate in thermocool mode, the coolflow pump only stayed in low velocity.The high flow had to be activated manually.They tried the same cable with another coolflow pump and it worked normally.There was no patient injury reported in this procedure.On january 7, 2014 additional information was received on the event stating the ablation had initiated and the coolflow pump did not change to high flow.After, on march 24, 2014, additional clarification was received which stated that the generator cannot activate when the pump was at low flow.This is a safety feature of the cool flow 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.The device was evaluated and several plugs were reconnected to resolve the issue.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: 3585126
• MDR Text Key: 20007195
• Report Number: 1721752-2014-00002
• 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: 01/07/2014

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: 01/07/2014
• Initial Date FDA Received: 01/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1