MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTICGEL PADS

Model Number 50000000E

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the nurse was trying to warm a 10 month old patient from 35c to 36c using the arctic sun device but the patient was not warming.The water was not getting any warmer either.Device was giving alert 113 (reduced water temperature control) and the device was currently stopped.Nurse resumed therapy, flow rate was 0.6 lpm and pad lot number was ngfu2455 (product code 31700).Mss explained that this was a universal pad used for adult patients to cover exposed abdomen.Mss suggested getting small universal pad(s) or another universal pad, if there was not enough room on the patient to add another pad and place it to the side.Mss stated that the flow rate was too low for the heater to work appropriately.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned.A potential root cause for this failure could be "belt temperatures too low after nip roller and heated section".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "arcticgel¿ pads are only for use with an arctic sun® temperature management system control module.See operators manual for detailed instructions on system use.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 entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved.For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application.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.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.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).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." h11: section a through f - 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 nurse was trying to warm a 10 month old patient from 35c to 36c using the arctic sun device but the patient was not warming.The water was not getting any warmer either.Device was giving alert 113 (reduced water temperature control) and the device was currently stopped.Nurse resumed therapy, flow rate was 0.6 lpm and pad lot number was ngfu2455 (product code 31700).Mss explained that this was a universal pad used for adult patients to cover exposed abdomen.Mss suggested getting small universal pad(s) or another universal pad, if there was not enough room on the patient to add another pad and place it to the side.Mss stated that the flow rate was too low for the heater to work appropriately.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14516472
• MDR Text Key: 292795003
• Report Number: 1018233-2022-04134
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071225
• UDI-Public: (01)00801741071225
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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: 07/31/2023
• Device Model Number: 50000000E
• Device Catalogue Number: 317-00-04
• Device Lot Number: NGFU2455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2021
• 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): Other