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

Model Number M-5491-01

Device Problems Intermittent Continuity (1121); Material Too Rigid or Stiff (1544); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

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 a procedure with a coolflow pump and a high flow rate activation issue occurred.The pump intermittently failed to start when radiofrequency was switched on.In addition, the bubble alarm seemed to go off constantly as well as the pump door seemed to be very stiff.The procedure was completed with no patient consequence.Upon request additional information was received on the event.The pump was set to switch on automatically when the stockert generator is switched on.The flow issue has been an ongoing problem over multiple procedures where the hospital staff has managed by taping the cable to the back of the pump.The bubble alarm sounds as soon as the pump is switched on.There were no actual bubbles seen.This complaint is being reported due to the pump not starting when radiofrequency was switched on as this could potentially cause patient injury.The other issues are not indicative of reportable events as they are highly detectable with low patient risk.

Manufacturer Narrative

This event has been reassessed as not mdr reportable.It was originally reported that the cool flow pump failed to activate high flow irrigation during ablation.However, additional information was received that indicates that the stockert generator sensed that the pump did not spool up and did not allow for radiofrequency ablation energy to be delivered during that time.As such, the device functioned as intended because if there is no flow the generator cannot deliver radiofrequency.The potential that this could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Due to the (b)(4) 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).Manufacturer's ref.No: (b)(4).It was reported that the pump intermittently failed to start when radiofrequency was switched on.In addition, the bubble alarm seemed to go off constantly as well as the pump door seemed to be very stiff.The device was evaluated.Bu error was confirmed.Door was difficult to open.Rf error was not duplicated.Bubble sensor and door assembly were replaced and the issue was resolved.The device was also subjected to preventative maintenance, safety and functional testing and all tests passed.

• 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: joaquin kurz ; 9497893837
• MDR Report Key: 5097371
• MDR Text Key: 26854493
• Report Number: 1721752-2015-00018
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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: 09/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1