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

Model Number M-5491-01

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

It was reported that, during an atrial fibrillation ablation procedure, the system switched automatically from high to low flow.The procedure was complete using another pump.No adverse patient consequences were reported.Upon request, additional information was received stating that neither error nor warning message appeared when the pump was delivering low flow.Additionally, no ablation was performed when the pump switched to low flow, since this malfunction occurred after pressing the ablation pedal triggering the high flow, but before actual ablation could be delivered (normal delay of 5 secs).All lights were green and indicated that ablation would have been possible, had the physician not noticed the low flow, making the event reportable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).It was reported that, during an atrial fibrillation ablation procedure, the system switched automatically from high to low flow.The procedure was complete using another pump.No adverse patient consequences were reported.Upon request, additional information was received stating that neither error nor warning message appeared when the pump was delivering low flow.Additionally, no ablation was performed when the pump switched to low flow, since this malfunction occurred after pressing the ablation pedal triggering the high flow, but before actual ablation could be delivered (normal delay of 5 secs).All lights were green and indicated that ablation would have been possible, had the physician not noticed the low flow, making the event reportable.After unit evaluation it was determined the system was tested and it was determined there was an interfaced board issue.The issue was resolved after resoldered joint on interface-board.The device was also subjected to pm, safety and functional testing and all tests passed.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.Customer¿s complaint was confirmed.

• 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: 3663275
• MDR Text Key: 19296018
• Report Number: 1721752-2014-00004
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/03/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 03/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1