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

Catalog Number 317-09

Device Problems Air Leak (1008); Insufficient Flow or Under Infusion (2182)

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.

Event Description

It was reported that there was an air leak and low flow alert during therapy.Therapy was interrupted in order to place the patient onto a second device; however, the low flow and air leak continued.Therapy was interrupted in order to replace the pads on the patient with a new set of pads; however, the low flow and air leak continued.As a result, therapy was discontinued on the second arctic sun and the patient's temperature was maintained using other means.

Manufacturer Narrative

Received 1 used large arctic gel pad kit only.The visual inspection noted the left thigh pad appeared to have a bent/damaged connector.During the functional evaluation, the pads were submitted to the flow rate test with the arctic sun machine model 2000 for 10 minutes and the results are as follows: left chest pad: a total of 3.90 l/min m2 of flow rate were registered during the test.Left thigh pad: a total of 3.18 l/min m2 of flow rate were registered during the test.Right chest pad: a total of 2.92 l/min m2 of flow rate were registered during the test.Right thigh pad: a total of 5.09 l/min m2 of flow rate were registered during the test.According the test method, the flow rate was found to be within specifications for all of the returned pads.The flow rate for this product must be above 2.4 l/min m2.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state 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 there was an air leak and low flow alert during therapy.Therapy was interrupted in order to place the patient onto a second device; however, the low flow and air leak continued.Therapy was interrupted in order to replace the pads on the patient with a new set of pads; however, the low flow and air leak continued.As a result, therapy was discontinued on the second arctic sun and the patients temperature was maintained using other means.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTIC SUN 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 ; 7707846130
• MDR Report Key: 6056700
• MDR Text Key: 58775291
• Report Number: 1018233-2016-01467
• 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: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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