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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS; NEONATAL PAD
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| Catalog Number 318-02 |
| Device Problems
Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964); Temperature Problem (3022); Non Reproducible Results (4029)
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| Patient Problems
Bradycardia (1751); Death (1802); Encephalopathy (1833); Sepsis (2067); No Consequences Or Impact To Patient (2199); Respiratory Failure (2484)
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| Event Date 05/08/2020 |
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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.The device was not returned.
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Event Description
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It was reported on 08may2020 that the arctic sun device, sn (b)(4), with neonatal pad lot number, ngen1815, was displaying an alarm 113; reduced water temperature control and an alert 02; low flow.This occurred during the cooling phase of therapy for a (b)(6)- day old neonate with hypoxic ischemic encephalopathy.The nurse changed the neonatal pad to a pad from lot number, ngdz2984, but the issues persisted.The nurse then phoned ms&s for troubleshooting assistance.The target temperature was 33.5 c.The patient¿s temperature was 32.6 c.The water temperature was 28.9 c.The flow rate was between 0.3-0.4l/min.The inlet pressure was -4 psi.The event log confirmed the alarm 113 and the alert 02.The pads were disconnected and reconnected using proper technique.The patient¿s temperature decreased to 32.4 c.The water temperature was 29c.The flow rate was 0.4 l/min.The inlet pressure was -7psi.The water level showed 2 bars.The nurse was advised to switch the device out and send it to biomed and save the pads for return.Per additional information received by the fa specialist on 09may2020, the nurse continued therapy with a different device, sn (b)(4), but used the same neonatal pad with lot number, ngdz2984.The second device gave an alarm 113 on (b)(6) 2020 and the pad was then changed.Additional information was received on 01jun2020 via a medwatch that both devices were evaluated by the facility biomed department and the failures were unable to be duplicated.Both devices reportedly passed functional tests and were placed back into service.The risk manager reported on 02jun2020 during a follow-up phone call that the neonate was able to reach target temperature on the second device, without issue, after the pad was changed out.The risk manager also reported that the newborn expired on (b)(6) 2020 during the rewarming phase of therapy and stated the death was not device related.The cause of death documented in the medical record was respiratory failure secondary to bacterial sepsis and ischemic encephalopathy.The risk manager reported other medical diagnoses included neonatal bradycardia and ventilator dependency.
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Event Description
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It was reported on 08may2020 that the arctic sun device, sn (b)(6) with neonatal pad lot number, ngen1815, was displaying an alarm 113; reduced water temperature control and an alert 02; low flow.This occurred during the cooling phase of therapy for a two- day old neonate with hypoxic ischemic encephalopathy.The nurse changed the neonatal pad to a pad from lot number, ngdz2984, but the issues persisted.The nurse then phoned ms&s for troubleshooting assistance.The target temperature was 33.5 c.The patient¿s temperature was 32.6 c.The water temperature was 28.9 c.The flow rate was between 0.3-0.4l/min.The inlet pressure was -4 psi.The event log confirmed the alarm 113 and the alert 02.The pads were disconnected and reconnected using proper technique.The patient¿s temperature decreased to 32.4 c.The water temperature was 29c.The flow rate was 0.4 l/min.The inlet pressure was -7psi.The water level showed 2 bars.The nurse was advised to switch the device out and send it to biomed and save the pads for return.Per additional information received by the fa specialist on 09may2020, the nurse continued therapy with a different device, sn dybwy508, but used the same neonatal pad with lot number, ngdz2984.The second device gave an alarm 113 on 09may2020 and the pad was then changed.Additional information was received on 01jun2020 via a medwatch that both devices were evaluated by the facility biomed department and the failures were unable to be duplicated.Both devices reportedly passed functional tests and were placed back into service.The risk manager reported on 02jun2020 during a follow-up phone call that the neonate was able to reach target temperature on the second device, without issue, after the pad was changed out.The risk manager also reported that the newborn expired on 11may2020 during the rewarming phase of therapy and stated the death was not device related.The cause of death documented in the medical record was respiratory failure secondary to bacterial sepsis and ischemic encephalopathy.The risk manager reported other medical diagnoses included neonatal bradycardia and ventilator dependency.
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Manufacturer Narrative
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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 a thermal regulating system, indicated 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 non-invasive thermoregulatory system.¿ do not place the neonatal arcticgel¿ pad on skin that has signs of ulcerations, burns, hives or rash.¿ do not remove the fabric release liner of the neonatal arcticgel¿ pad and expose the hydrogel.¿ do not place the neonatal arcticgel¿ pad hydrogel on immature (non-keratinized) skin or premature babies.¿ 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 the neonatal arcticgel¿ pad over transdermal medication patches as warming can increase drug delivery and cooling can reduce the 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.¿ the neonatal arcticgel¿ pad is only for use with the arctic sun® temperature management system.¿ 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.¿ 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, steroid use, or high dose vasopressor therapy.If accessible, examine the patient¿s skin under the neonatal arcticgel¿ pad 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 neonatal arcticgel¿ pad.¿ do not place any positioning devices under the pad manifolds or patient lines.¿ if warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.¿ do not allow urine, stool, antibacterial solutions or other agents to pool underneath the neonatal arcticgel¿ pad.Urine, stool and antibacterial agents can absorb into the pad hydrogel and cause chemical injury, skin irritation, and loss of pad adhesion over time.Replace pads immediately if these fluids come into contact with the hydrogel.¿ do not place the neonatal arcticgel¿ pad directly over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.¿ if needed, place defibrillation pads between neonatal arcticgel¿ pad and the patient¿s skin.¿ the neonatal arcticgel¿ pad is 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.¿ the neonatal arcticgel¿ pad should not be punctured with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.¿ the neonatal arcticgel¿ pad must be replaced after 120 hours (5 days) of use.¿ do not allow circulating water to contaminate the sterile field when lines are disconnected.¿ discard used neonatal arcticgel¿ pad in accordance with hospital procedures for medical waste.Directions 1.Place the patient (1.8 - 4.5 kg; 4.0 - 9.9 lb) on the pad.Avoid placing the patients over the manifolds or other high pressure locations.The rate of temperature change and potentially the final achievable temperature is affected by pad surface area coverage, placement, patient size, and water temperature range.2.The pad surface must be contacting the skin for optimal energy transfer efficiency.A) if desired, the center section of the pad can be wrapped around the patient¿s torso and secured in place using the velcro tabs provided.¿ if this option is in use, ensure that the edges of the pad are away from articulating areas of the body to avoid irritation.¿ place pads to allow for full respiratory excursion.(e.G.Ensure free movement of the chest and abdomen are guaranteed).¿ the pads may be removed and reapplied if necessary.¿ pads should be placed on healthy, clean skin only.3.Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb) and the potential for rapid patient temperature change, it is recommended to use the following settings to the arctic sun® temperature management system: ¿ water temperature high limit: =40°c (104°f) ¿ water temperature low limit: =10°c (50°f) ¿ control strategy: 2 4.Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb) it is recommended to use the patient temperature high and patient temperature low alert settings.5.Place a core patient temperature probe and connect to the arctic sun® temperature management system patient temperature 1 connector for continuous patient temperature feedback.A rectal or esophageal temperature probe is recommended.6.Verify patient core temperature with an independent temperature probe before and at regular intervals during use.7.Attach the pad¿s line connectors to the fluid delivery line manifolds.8.See arctic sun® temperature management system operators manual and help screens for detailed instructions on system use.9.Begin treating the patient.10.If the pad fails to prime or a significant continuous air leak is observed in the pad return line, check the connections, then if needed, replace the leaking pad.Once the pad is primed, assure the steady state flow rate displayed on the control panel is appropriate.The minimum flow rate should be 1.1 l/m.11.When finished, purge water from pad.".
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