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Catalog Number 317-07-02 |
Device Problems
Inaccurate Flow Rate (1249); Output below Specifications (3004); Protective Measures Problem (3015)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the arctic sun device displayed a low flow alert.The flow rate was 1.4 lpm.The complainant emptied the pads, reconnected the pads, and checked for any leaks without resolve.The complainant tried switching to four different arctic sun devices but the flow rate remained below 1.5 lpm.The gel pads were changed and the flow rate increased to 1.7-1.8 lpm.Therapy was continued.
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Event Description
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It was reported that the arctic sun device displayed a low flow alert.The flow rate was 1.4 lpm.The complainant emptied the pads, reconnected the pads, and checked for any leaks without resolve.The complainant tried switching to four different arctic sun devices but the flow rate remained below 1.5 lpm.The gel pads were changed and the flow rate increased to 1.7-1.8 lpm.Therapy was continued.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential failure mode could be '3.2.Device not properly connected to as resulting in low flow rate¿ with a potential root cause of '3.2.1 inadequate labeling of device for proper connection.Improper design of pad connector- pad not connected to fluid delivery line.Pad connector not properly attached to fluid delivery line.¿ 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: ¿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 usersettable 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." correction: d10 (concomitant medical products), h3 (device evaluated by mfr).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.
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Manufacturer Narrative
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The reported event was confirmed.Visual evaluation of the returned sample noted one opened (no original packaging present), medium 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.Visual inspection of the tubing for all the pads noted no kinks.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 the right chest pad and the right thigh pads and unacceptable for the left chest and the left thigh pads.(acceptable range > 2.4 l/min.M2).Additionally, during testing of the left chest pad and the right thigh pad there was a low air leak message present.A potential root cause for this failure could be ' inadequate labeling of device for proper connection.Improper design of pad connector- pad not connected to fluid delivery line.Pad connector not properly attached to fluid delivery line.' 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: ¿¿ 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 usersettable 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." correction: d4, d10, h3, h6, additional event information.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.
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Event Description
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It was reported that the arctic sun device displayed a low flow alert.The flow rate was 1.4 lpm.The complainant emptied the pads, reconnected the pads, and checked for any leaks without resolve.The complainant tried switching to four different arctic sun devices but the flow rate remained below 1.5 lpm.The gel pads were changed and the flow rate increased to 1.7-1.8 lpm.Therapy was continued.
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Search Alerts/Recalls
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