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

Device Problem Temperature Problem (3022)

Patient Problems Death (1802); Burn, Thermal (2530)

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.The device was not returned.

Event Description

It was reported that 6 universal pads had been applied to patient in the early hours.There had been low water flow rate for numerous hours and the water temp was 4 degrees.The patient experienced skin damage, with thermal injuries to the abdomen.The pads were changed to the correct sized pads, and the water temp was at 20 degrees an hour later.The clinical nurse educator had completed their internal tissue viability form.No photos were available.Clinical nurse educator will check on how often skin checks were performed.The skin damage was not treated and therapy was continued with the correct set of pads.When the pads were removed, the skin returned to normal color.It was stated by the facility that the patient passed away the following day after the event, but the passing was unrelated to the device.Clinical statement: the patient¿s reported death was an incidental element of the patient¿s medical history and is unrelated to the reason for the complaint. there is no indication, report or allegation that the device malfunction was related to the patient's death.

Manufacturer Narrative

The device was not returned for evaluation.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 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.The device was not returned.

Event Description

It was reported that 6 universal pads had been applied to the patient in the early hours.There had been a low water flow rate for numerous hours and the water temperature was 4 degrees.The patient experienced skin damage, with thermal injuries to the abdomen.The pads were changed to the correct sized pads, and the water temp increased to 20 degrees an hour later.The clinical nurse educator had completed their internal tissue viability form.No photos were available.The clinical nurse educator will check on how often skin checks were performed.The skin damage was not treated and therapy was continued with the correct set of pads.When the pads were removed, the skin returned to normal color.It was stated by the facility that the patient passed away the following day after the event; however, the cause was unrelated to the device.Clinical statement: the patient¿s reported death was an incidental element of the patient¿s medical history and is unrelated to the reason for the complaint. there is no indication, report or allegation that the device malfunction was related to the patient's death.

• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6519556
• MDR Text Key: 73818478
• Report Number: 1018233-2017-02051
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• 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