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

Model Number M-5491-02

Device Problems Air Leak (1008); Invalid Sensing (2293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2016

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.This coolflow pump was manufactured before september 24, 2014; therefore no udi is applicable for this product with serial number (b)(4).

Event Description

It was reported that a coolflow irrigation pump was not sensing bubbles during use with a tubing set.No alarms or errors were noted on the pump.No procedure was taking place or patient consequence indicated.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event is mdr reportable because if the bubble sensor fails to detect the air bubbles, then it could lead to air embolism.

Manufacturer Narrative

(b)(4).It was reported that a coolflow® irrigation pump was not sensing bubbles during use with a tubing set.Complaint was not confirmed.Physical damage was found.Damaged splash hood and defective rotor pump was replaced and needs alignment.Performed preventative maintenance, sb9 upgrade and safety tests performed.System ready for use.The device history record 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6255026
• MDR Text Key: 65356062
• Report Number: 1721752-2017-00001
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071/S5
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-5491-02
• Device Catalogue Number: CFP002
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1