MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 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 during therapy there were alerts for air in line and low flow.Therapy was interrupted in order to put the patient onto a different device, but the issue remained.Therapy was interrupted in order to replace the pads with a new set of medium pads.Therapy was resumed without further issue with the new set of pads.

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 during therapy there were alerts for air in line and low flow.Therapy was interrupted in order to put the patient onto a different device, but the issue remained.Therapy was interrupted in order to replace the pads with a new set of medium pads.Therapy was resumed without further issue with the new set of pads.

Manufacturer Narrative

Received 4 of 4 used arctic gel pads.The reported event is unconfirmed, as the device operated within specifications.The visual inspection noted no obvious defects that could have contributed to the reported problem.During the functional evaluation, the pads were submitted to the flow rate test with an arctic sun machine model 2000 as follows: the pads were connected to the arctic sun machine model 2000 for a duration of 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 3.82 l/min m2 of flow rate were registered during the test.Right chest pad: a total of 3.78 l/min m2 of flow rate were registered during the test.Right thigh pad: a total of 4.45 l/min m2 of flow rate were registered during the test.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 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 during therapy, the device produced "air in line" and "low flow" alerts.As a result, therapy was interrupted in order to place the patient onto a second device; however, the issue was unresolved.Therapy was again interrupted in order to replace the pads with a new set of medium pads.Subsequently, therapy was resumed without any further issues.

• Brand Name: ARCTIC SUN 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5934444
• MDR Text Key: 54652686
• Report Number: 1018233-2016-01187
• 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: 09/26/2016

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: 05/31/2017
• Device Catalogue Number: 317-09
• Device Lot Number: NGAS0718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/26/2016; 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2016
• 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