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

Catalog Number 317-09

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

Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

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 when the patient returned from a cat scan, an alert 01 and 02 occurred and therapy could not be resumed; however, the patient needed to cool for six more hours.The patient's temperature was 33.6c with a target temperature of 33c.In manual mode with only the fluid delivery line attached, the flow rate was 2.2lpm, the inlet pressure, and the circulation pump command was 69%.The nurse connected the left thigh pad, left chest pad and the right chest pad once at a time on different valve sets.The inlet pressure was between -0.6 and -.2.4psi.Therapy was interrupted in order to replace the pads with a second set of pads.Therapy was resumed using the second set of pads and the flowrate was optimal.

Event Description

It was reported that when the patient returned from a cat scan, an alert 01 and 02 occurred and therapy could not be resumed; however, the patient needed to cool for six more hours.The patient's temperature was 33.6c with a target temperature of 33c.In manual mode with only the fluid delivery line attached, the flow rate was 2.2lpm, the inlet pressure, and the circulation pump command was 69%.The nurse connected the left thigh pad, left chest pad and the right chest pad once at a time on different valve sets.The inlet pressure was between -0.6 and -.2.4psi.Therapy was interrupted in order to replace the pads with a second set of pads.Therapy was resumed using the second set of pads and the flowrate was optimal.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.A potential failure mode could be '3.3 poor flow¿ with a potential root cause of 'improper storage causing crushed pad, pad dimples, and/or pad lines.¿ the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.".

• Brand Name: ARCTICGEL PADS
• Type of Device: ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8607766
• MDR Text Key: 145101860
• Report Number: 1018233-2019-02498
• 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
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1