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

Model Number M-5491-01

Device Problems Air Leak (1008); Device Alarm System (1012); Failure to Sense (1559)

Patient Problem Air Embolism (1697)

Event Date 03/12/2014

Event Type  malfunction  

Event Description

During a procedure, it was reported that air bubble was noted in the tubings.The air was in the vascular system.After the procedure, the patient was checked and found stable, there were no consequences.On march 19th, received additional information requested from bwi representative stating that the pump sensor did not detect the air bubbles; therefore, no alarm error was displayed.Based on the additional information, the bubble sensor failed to detect the air bubbles.This could lead a potential risk to the patient.Therefore, this complaint became reportable.(b)(4).

Manufacturer Narrative

The equipment investigation is still in progress.(b)(4).

Manufacturer Narrative

(b)(4).During a procedure, it was reported that air bubble was noted in the tubings.The air was in the vascular system.After the procedure, the patient was check and found stable, there were no consequences.On march 19th, received additional information requested from bwi representative stating that the pump sensor did not detect the air bubbles therefore, no alarm error was displayed.The equipment was evaluated and found physical damage as well as the bu sensors found defective.The bubble sensors, door window, ground strap and pcb interface were replaced.The equipment was also subjected to pm, safety and functional testing and all tests passed.The system is ready for use.The device history records 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.The customer 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: 3727515
• MDR Text Key: 4324825
• Report Number: 1721752-2014-00007
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• 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: 03/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1