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

Catalog Number 317-05-02

Device Problems Insufficient Flow or Under Infusion (2182); Gas/Air Leak (2946)

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 the arctic sun device showed low flow.The patient temperature was 35.9c, target temperature was 33, water temperature 6.9, flow rate 0.7lpm when small pads were used.Initial inlet pressure was -3psi, system hours 838, pump hours 655.When the complainant disconnected and reconnected pads using proper technique and the fluid rate was 2.3lpm but it dropped later and alerted low air leak ( alert 02 ) again.The therapy was stopped and the pads were disconnected or emptied.When placed in manual control, just fluid delivery line, the flow rate was 1.8lpm, inlet pressure -7psi, circulation pump 55%.The right chest pad had a flow rate of 2.1lpm, inlet pressure -2.3psi and circulation pump 100.Manual control was disabled.Therapy was continued.The nurse stated that the set of pads would be changed and call if needed.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.The reported event could not be confirmed.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be, "user cuts or punctures pads 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: ¿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." 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.H3 other text : the device was not returned.

Event Description

It was reported that the arctic sun device showed low flow.The patient temperature was 35.9c, target temperature was 33, water temperature 6.9, flow rate 0.7lpm when small pads were used.Initial inlet pressure was -3psi, system hours 838, pump hours 655.When the complainant disconnected and reconnected pads using proper technique and the fluid rate was 2.3lpm but it dropped later and alerted low air leak ( alert 02 ) again.The therapy was stopped and the pads were disconnected or emptied.When placed in manual control, just fluid delivery line, the flow rate was 1.8lpm, inlet pressure -7psi, circulation pump 55%.The right chest pad had a flow rate of 2.1lpm, inlet pressure -2.3psi and circulation pump 100.Manual control was disabled.Therapy was continued.The nurse stated that the set of pads would be changed and call if needed.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10092856
• MDR Text Key: 193701248
• Report Number: 1018233-2020-03430
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-05-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1