MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS ARCTIC SUN GEL PADS

Catalog Number 317-05

Device Problems Display or Visual Feedback Problem (1184); Inaccurate Flow Rate (1249)

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. 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.

Event Description

It was reported that the arcticsun device was displaying low flow alert 02. The patient temperature was 36. 5c and the target temperature was 36c. The device was switched and the alert returned. Per troubleshooting the pads were disconnected and reconnected using proper technique with no change in flow. Took off fdl and ran diagnostics, then reconnected pads one by one and flow dropped again. They were advised to switch out pads. Per additional information received on (b)(6) 2019, the patient was able to complete therapy on the second set of pads.

Event Description

It was reported that the arcticsun device was displaying low flow alert 02. The patient temperature was 36. 5c and the target temperature was 36c. The device was switched and the alert returned. Per troubleshooting the pads were disconnected and reconnected using proper technique with no change in flow. Took off fdl and ran diagnostics, then reconnected pads one by one and flow dropped again. They were advised to switch out pads. Per additional information received on 13 march 2019, the patient was able to complete therapy on the second set of pads.

Manufacturer Narrative

The reported event could not be confirmed. Visual evaluation of the returned sample noted one opened (no original packaging present), used arctic gel pad kit present. All four pads were returned. 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. The zippered sample container bags were adhered to the hydrogel of the returned pads to simulate a liner replacement. According to the test method, the flow rate was found to be acceptable for all returned pads. (acceptable range 2. 4 l/min. M2). 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: "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. " 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: ARCTICGEL PADS
• Type of Device: ARCTIC SUN GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8449788
• Report Number: 1018233-2019-01517
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 317-05
• Device Lot Number: NGCW2185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No