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); Device Displays Incorrect Message (2591); Improper Device Output (2953)

Patient Problem Alteration In Body Temperature (2682)

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 the device produced a "low flow" and "low air leak" alert.The nurse reported that she noticed air bubbles in the clear connectors.The patient's temperature was 31.9°c and the flow rate was 0.7lpm.The nurse reported erratic patient temperature, so the esophageal probe was changed.Subsequently, the device produced an alarm 15, alert 51 and alert 113.The pads were disconnected and reconnected; however, the flow rate remained at 0.7lpm.As a result.The pads were replaced; however, the flow only increased to 2.0lpm.Therapy was interrupted in order to place the patient on a second device, and therapy was resumed on the second device without any further issues.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the device produced a "low flow" and "low air leak" alert.The nurse reported that she noticed air bubbles in the clear connectors.The patient's temperature was 31.9°c and the flow rate was 0.7lpm.The nurse reported erratic patient temperature, so the esophageal probe was changed.Subsequently, the device produced an alarm 15, alert 51 and alert 113.The pads were disconnected and reconnected; however, the flow rate remained at 0.7lpm.As a result; the pads were replaced, however the flow only increased to 2.0lpm.Therapy was interrupted in order to place the patient on a second device, and therapy was resumed on the second device without any further issues.

Manufacturer Narrative

Received 1 used large arcticgel pad kit with the original unit packaging.Visual inspection noted no obvious defects that would have contributed to the reported problem.The pads were reviewed and were noted to have use evidence.It was found that the pads' trim pattern was correct, and the energy connectors were found free of damages and presented a good connection.Per the functional evaluation, the pads were submitted to the flow rate test with the arctic sun machine model 2000.The pads were connected to the arctic sun machine model 2000 for 10 minutes, see details below: left chest pad: a total of 3.04 l/min m2 of flow rate were registered during the test; left thigh pad: a total of 3.02 l/min m2 of flow rate were registered during the test; right chest pad: a total of 2.44 l/min m2 of flow rate were registered during the test; right thigh pad: a total of 2.54 l/min m2 of flow rate were registered during the test.The flow rate was found to be acceptable on all of the returned pads.Per specification, the flow rate for this product must be above 2.4 l/min m2.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿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 device produced a "low flow" and "low air leak" alert.The nurse reported that she noticed air bubbles in the clear connectors.The patient's temperature was 31.9°c and the flow rate was 0.7lpm.The nurse reported erratic patient temperature, so the esophageal probe was changed.Subsequently, the device produced an alarm 15, alert 51 and alert 113.The pads were disconnected and reconnected; however, the flow rate remained at 0.7lpm.As a result; the pads were replaced, however the flow only increased to 2.0lpm.Therapy was interrupted in order to place the patient on a second device, and therapy was resumed on the second device without any further issues.

• 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 ; 7707846100
• MDR Report Key: 6136335
• MDR Text Key: 61495647
• Report Number: 1018233-2016-01718
• 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,Followup
• Report Date: 12/15/2016

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 Expiration Date: 02/28/2017
• Device Catalogue Number: 317-09
• Device Lot Number: NGAP2007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2016; 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2016
• 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