|
Catalog Number 317-07-02 |
Device Problems
Inaccurate Flow Rate (1249); Therapeutic or Diagnostic Output Failure (3023)
|
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 patient was not cooling on the arctic sun device.Complainant stated they had been receiving an alert 113 about every three minutes since around 1pm.Patient was 36.1c, target was 36c, water was 28.6c, and flow rate was 1.1 l/m.Pads were medium and there was some exposed area.Complainant disconnected and reconnected pads before calling and flow had been lower since the alert 113 started.T1 was 36.1 c, t3 was 28.6c, t4 was 4.3c, wfr was 1.1 l/, inlet pressure was -7 psi, circulation pump was 36%, mixing pump was 100% , and wrl was 4.System hours were 5864.9 and pump hours were 5223.3.Ms&s advised nurse to swap out device.Complainant confirmed they have another device available on the floor that she can use.Biomed (b)(6) called later that day to troubleshoot the alert 113.He placed the device in manual control and the water was full.The device heated to 42.In manual control the device read: t1 at 38c, t2 at 38c, t4 at 3.9c, and mixing pump at 100%.Call transferred to tech support.As per follow up information, (b)(6) who confirmed patient was continuing therapy with no further issues on the second device.First device was with biomed.(b)(6) who confirmed a failed mixing pump.The device will return to the depot for a pm.
|
|
Event Description
|
It was reported that the patient was not cooling on the arctic sun device.Complainant stated they had been receiving an alert 113 about every three minutes since around 1pm.Patient was 36.1c, target was 36c, water was 28.6c, and flow rate was 1.1 l/m.Pads were medium and there was some exposed area.Complainant disconnected and reconnected pads before calling and flow had been lower since the alert 113 started.T1 was 36.1 c, t3 was 28.6c, t4 was 4.3c, wfr was 1.1 l/, inlet pressure was -7 psi, circulation pump was 36%, mixing pump was 100% , and wrl was 4.System hours were 5864.9 and pump hours were 5223.3.Ms&s advised nurse to swap out device.Complainant confirmed they have another device available on the floor that she can use.Biomed called later that day to troubleshoot the alert 113.He placed the device in manual control and the water was full.The device heated to 42.In manual control the device read: t1 at 38c, t2 at 38c, t4 at 3.9c, and mixing pump at 100%.Call transferred to tech support.As per follow up information, hannah who confirmed patient was continuing therapy with no further issues on the second device.First device was with biomed.Kevin who confirmed a failed mixing pump.The device will return to the depot for preventive maintenance (pm).
|
|
Manufacturer Narrative
|
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section." the lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indications for use ¿ the arctic sun® temperature management system is intended for monitoring and controlling patient temperature in adult and pediatric patients of all ages.Contraindications ¿ there are no known contraindications for the use of a thermoregulatory system.¿ do not place arcticgel¿ pads on skin that has signs of ulcerations, burns, hives or rash.¿ while there are no known allergies to hydrogel materials, caution should be exercised with any patient with a history of skin allergies or sensitivities.Warning ¿ do not place arcticgel¿ pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.Cautions ¿ federal law restricts this device to sale by or on the order of a physician.¿ this product is to be used by or under the supervision of trained, qualified medical personnel.¿ the clinician is responsible for determining the appropriateness of use of this device and the user settable parameters, including water temperature, for each patient.For small patients (=30 kg) it is recommended to use the following settings: water temperature high limit =40°c (104°f); water temperature low limit =10°c (50°f); control strategy =2.It is recommended to use the patient temperature high and patient temperature low alert settings.¿ due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold.Patients at risk include those with poor tissue perfusion or poor skin integrity due to edema, diabetes, peripheral vascular disease, poor nutritional status or steroid or high dose vasopressor therapy.If accessible, examine the patient¿s skin under the arcticgel¿ pads often; especially those patients at higher risk of skin injury.¿ skin injury may occur as a cumulative result of pressure, time and temperature.Possible skin injuries include bruising, tearing, skin ulcerations,blistering, and necrosis.Do not place bean bags or other firm positioning devices under the arcticgel¿ pads.Do not place any positioning devices under the pad manifolds or patient lines.¿ do not allow urine, antibacterial solutions or other agents to pool underneath the arcticgel¿ pads.Urine and antibacterial agents can absorb into the pad hydrogel and cause chemical injury and loss of pad adhesion.Replace pads immediately if these fluids come into contact with the hydrogel.¿ do not place arcticgel¿ pads directly over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ carefully remove arcticgel¿ pads from the patient¿s skin at the completion of use.Aggressive removal or removal of cold pads from the patient¿s skin may result in skin tears.¿ the arcticgel¿ pads are non-sterile for single patient use only.Do not place pads in the sterile field.If used in a sterile environment, pads should be placed according to the physician¿s directions, either prior to the sterile preparation or sterile draping.¿ do not reprocess or sterilize.¿ use pads immediately after opening.Do not store pads in opened pouch.¿ do not allow circulating water to contaminate the sterile field when lines are disconnected.¿ the arcticgel¿ pads should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.¿ if warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.¿ the arcticgel¿ pads are only for use with an arctic sun® temperature management system.¿ the water content of the hydrogel affects the pad¿s adhesion to the skin and conductivity, and therefore, the efficiency of controlling patient temperature.Periodically check that pads remain moist and adherent.Replace pads when the hydrogel no longer uniformly adheres to the skin.Replacing pads at least every 5 days is recommended.¿ if needed, place defibrillation pads between the arcticgel¿ pads and the patient¿s skin.¿ discard used arcticgel¿ pads in accordance with hospital procedures for medical waste.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.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.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.
|
|
Search Alerts/Recalls
|
|
|