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

Catalog Number 317-09-02

Device Problems Device Alarm System (1012); Break (1069); Inaccurate Flow Rate (1249); Leak/Splash (1354); Pressure Problem (3012)

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 device was not returned.

Event Description

It was reported that the device displayed a low flow and low air leak.The flow was fine until the patient went to mri.Upon returning from mri the nurse reconnected the pads and the device started alerting.The patient¿s temperature was 36.6c and the target temperature was 36c.The device was off when the nurse disconnected and reconnected the pads multiple times without resolution.There were four large pads in place.Per troubleshooting, ms&s had the nurse restart therapy.System diagnostics showed the flow rate was 0.6l/min, inlet pressure was -2.8psi and the circulation pump was 100%.Multiple alert 01 and alert 02 were in the event log.Ms&s walked her through disconnecting and reconnecting the pads holding behind the clear clamps.Ms&s asked her to look for damage to the pads and initially she found none.Upon further inspection the nurse found one chest pad clear clamp was broken.The facility did not carry universal pads.Ms&s advised the nurse to change out the pads and save pads for field assurance.Ms&s called back one hour later to speak with nurse and she stated the flow rate was 3l/min and there were no further issues.Per follow up on 21nov2019, the male patient was able to complete therapy on the device but they had to switch out the pads.The device was kept in service.

Manufacturer Narrative

The reported event could not be confirmed as no sample was returned for evaluation.The potential failure modes could be "low flow / restricted flow rate due to the energy connector being damaged." with a potential root causes of '3.2.1 inadequate labeling of device for proper connection" and "received connectors damaged by supplier." 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 entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved.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 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).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." the device was not returned.

Event Description

It was reported that the device displayed a low flow and low air leak.The flow was fine until the patient went to mri.Upon returning from mri the nurse reconnected the pads and the device started alerting.The patient¿s temperature was 36.6c and the target temperature was 36c.The device was off when the nurse disconnected and reconnected the pads multiple times without resolution.There were four large pads in place.Per troubleshooting, ms&s had the nurse restart therapy.System diagnostics showed the flow rate was 0.6l/min, inlet pressure was -2.8psi and the circulation pump was 100%.Multiple alert 01 and alert 02 were in the event log.Ms&s walked her through disconnecting and reconnecting the pads holding behind the clear clamps.Ms&s asked her to look for damage to the pads and initially she found none.Upon further inspection the nurse found one chest pad clear clamp was broken.The facility did not carry universal pads.Ms&s advised the nurse to change out the pads and save pads for field assurance.Ms&s called back one hour later to speak with nurse and she stated the flow rate was 3l/min and there were no further issues.Per follow up on (b)(6) 2019, the male patient was able to complete therapy on the device but they had to switch out the pads.The device was kept in service.

• 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: 9460491
• MDR Text Key: 178579714
• Report Number: 1018233-2019-07925
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGCZ0256
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR