MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS; ARCTIC GEL PAD

Catalog Number 317-00

Device Problems Unintended Ejection (1234); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); 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.

Event Description

It was reported that there was gel oozing out of the arctic gel pad, and there were sections of the pad where the hydrogel had released from the backing.Per troubleshooting with ms&s, the nurse was advised to remove and replace the pad.

Event Description

It was reported that there was gel oozing out of the arctic gel pad, and there were sections of the pad where the hydrogel had released from the backing.Per troubleshooting with ms&s, the nurse was advised to remove and replace the pad.

Manufacturer Narrative

The reported event was unconfirmed since the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (no original packaging present), used large arctic gel pad kit and one universal pad present.All four pads from the kit were returned along with a universal pad.Visual inspection of the pad surface noted no obvious visible defects such as a cut or tear in the foam.Visual inspection of the clear connectors noted no visible chips and deformities at the ends of all connectors.Visual inspection of the tubing for all the pads noted no kinks.Zippered sample container bags were adhered to the hydrogel of the returned pads to simulate a liner replacement.No hydrogel peeled off any pad when separated from the liner.No melting or oozing of any pad was observed.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "directions for use 1.Arcticgel¿ pads are only for use with an arctic sun® temperature management system control module.See operators manual for detailed instructions on system use.2.Select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the maximum number and largest size pads.3.For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application.4.Place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion.5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.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 full pad kit.7.When finished, empty water from pads.Cold temperature increases the adhesiveness of the hydrogel.For ease of removal, leave pads on the patient for approximately 15 minutes to allow the hydrogel to warm.Slowly remove pads from the patient and discard." correction: h5 h11:section a through f - the information provided by bd 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 bd.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9180860
• MDR Text Key: 194473119
• Report Number: 1018233-2019-06414
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 317-00
• Device Lot Number: NGDP0743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1