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

Catalog Number 318-00

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

Patient Problem Alteration In Body Temperature (2682)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; however, based on the event description, was determined to be user related.Therefore, the reported event was confirmed as use-related.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "if the cap fails to prime or a significant continuous air leak is observed in the cap return line, check connections, then if needed replace the leaking cap.The cap should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance." (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.The device was not returned.

Event Description

It was reported that the neonatal pad was giving a flowrate of 0.7-0.9lpm during normothermia.The nurse also reported that she could hear a hissing sound coming from the pad.At the time of the call, the patient's temperature was 97.4f, the target was set to 98.6f and the water temperature was 93.7f.The event log revealed multiple alert 01's and an alert 113.The pad was disconnected and reconnected, but the flow initially stabilized at 1.1 lpm and decreased to 0.7lpm thereafter, with a low air leak.The pad was moved to different valve sets but the low air leak continued.The nurse reported that there was no obvious damage to the pad; however, the night nurse had reported that the staff had used scissors around the pad, but did not cut the pad.Therefore, the neonatal pad was swapped with a second neonatal pad and therapy resumed on the second neonatal pad without any further issues.

• Brand Name: ARCTICSUN 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: 6351892
• MDR Text Key: 68374681
• Report Number: 1018233-2017-00629
• 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
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 318-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• 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