MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS; ARCTICSUN GEL PADS

Catalog Number 317-07

Device Problems Contamination (1120); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964); No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that the patient soiled the first set of medium pads, resulting in a second set of medium pads being used on the patient.The second set of medium pads produced an alert 01 and alert 02.Per troubleshooting, the device was placed in manual mode with only the fdl attached, and the flow settled at 1.6lpm, the ip was -7.0psi and the circulation pump was at 58%.The left chest pad was attached and the circulation pump rose to 100%, and the ip was -0.7psi; however, there was no improvement when changing valve sets.The results were the same with the right chest pad, as the ip was -0.4psi and the water level was 4 bars.Therefore, the second set of medium pads were replaced with a third set of medium pads, which resulted in no flow.Subsequently, the arctic sun 5000 device was replaced with an arctic sun 2000 device, and therapy resumed on the third set of medium pads and the arctic sun 2000 without any further issues.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: ¿6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit.¿ (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the patient soiled the first set of medium pads, resulting in a second set of medium pads being used on the patient.The second set of medium pads produced an alert 01 and alert 02.Per troubleshooting, the device was placed in manual mode with only the fdl attached, and the flow settled at 1.6lpm, the ip was -7.0psi and the circulation pump was at 58%.The left chest pad was attached and the circulation pump rose to 100%, and the ip was -0.7psi; however, there was no improvement when changing valve sets.The results were the same with the right chest pad, as the ip was -0.4psi and the water level was 4 bars.Therefore, the second set of medium pads were replaced with a third set of medium pads, which resulted in no flow.Subsequently, the arctic sun 5000 device was replaced with an arctic sun 2000 device, and therapy resumed on the third set of medium pads and the arctic sun 2000 without any further issues.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTICSUN GEL PADS
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6309146
• MDR Text Key: 67120992
• Report Number: 1018233-2017-00340
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/18/2017

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 Catalogue Number: 317-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention