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

Catalog Number 317-07

Device Problem 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 the pads gave low flow and had to be replaced.

Manufacturer Narrative

Received 1 set of 2 unused arcticgel pads.The customer did not return the right thigh pad and the left torso pad for evaluation.Visual evaluation noted evidence of being used, the trim pattern on all four pads was found to be correct, the energy connectors were found free of damages and presented a good connection.Per functional evaluation the pads were submitted to the flow rate test with the arctic sun machine model 2000.The pad was connected to the arctic sun machine model 2000 for 10 minutes and the water immediately started flowing to the pad without any problems.Right chest pad: a total of 5.89 l/min m2 of flow rate were registered during the test.Left thigh pad: a total of 5.09 l/min m2 of flow rate were registered during the test.The reported event was unconfirmed as the reported event could not be reproduced.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states 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 fullpad 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.

• Brand Name: ARCTICGEL 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: 5333149
• MDR Text Key: 35068960
• Report Number: 1018233-2015-00624
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002577
• 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: 01/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 317-07
• Device Lot Number: NGZ10538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2015
• 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