MAUDE Adverse Event Report: HEI, INC. COOLFLOW® IRRIGATION PUMP; SIMILAR DEVICE CFP002, PMA # P990071/S5

Model Number M-5491-01

Device Problems Insufficient Flow or Under Infusion (2182); Difficult or Delayed Activation (2577); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2015

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 an atrial fibrillation (afib) procedure with a coolflow pump and stockert 70 system and there was a high flow rate activation problem.The stockert 70 system was displaying a low flow error when attempting to go on ablation.Later in the procedure, the coolflow pump was not spooling up to high flow when attempting to go on ablation.There was no error that populated.There was noise like when on ablation.However, the pump stayed at 2ml/min.The generator was set to auto mode.They confirmed that they had the correct catheter setting on the stockert 70 system.They were advised to disconnect and reconnect the cable connecting the stockert 70 system and coolflow pump.The issue then resolved.The procedure continued.There was no patient consequence.Since ablation is initiated and the irrigation pump does not change to high flow rate, this is a potential patient injury.Therefore, this issue has been assessed as reportable for the coolflow pump.Since the stockert 70 system was set to auto mode and the stockert 70 system did not populate an error during the high flow activation issue, this issue is also reportable under the stockert 70 system.

Manufacturer Narrative

In the original 3500a report, it was reported that the hardware investigation had begun and when the investigation would be completed, a supplemental 3500a report would be submitted.Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.(b)(b)(4).Evaluation, method - (actual device not tested).Results - (no malfunction found since device was not tested).Conclusion - (unable to confirm).(b)(4).

• Brand Name: COOLFLOW® IRRIGATION PUMP
• Type of Device: SIMILAR DEVICE CFP002, PMA # P990071/S5
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5065533
• MDR Text Key: 25935302
• Report Number: 1721752-2015-00017
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• 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
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1