MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS; ARCTICSUN GEL PADS
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Catalog Number 317-07-I |
Device Problems
Display or Visual Feedback Problem (1184); Restricted Flow rate (1248); Material Deformation (2976)
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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 an intrepid study site (b)(6) had a normothermia patient on s/n (b)(4).A nurse walked by (she was not the patient's nurse) and heard device beeping and reported that the device was beeping and displayed a "low air leak".The flow rate was 0.8l/min and then dropped to 0l/min.The patient temperature was 36.9c, the water temperature was 12c.The event log showed an alert 01 (patient line open) multiple times and an alert 02 (low flow).The trend indicator showed 2 arrows up.She reported that she disconnected and reconnected the pads to straighten out some bends/kinks.After re-connection the device began beeping, and displayed a"low air leak" and "pt line open".Four medium pads were in place.An attempt was made to restart the device and the device began to prime, then the flow rate went to 0 l/min.The nurse was guided through disconnecting and reconnecting the pads properly.The device attempted to prime once more and the flow rate went to 0 l/min.The nurse did not want to troubleshoot each pad.She noted that she planned change device and call back.The patient was placed on s/n (b)(4).At initiation, the device attempted to prime and the flow rate went to 0 l/min.She noted that she will obtain new pads and return to the call have assistance with pre-conditioning the pads per their protocol.The nurse called back and reported that the pads were exchanged and the patient was placed back on the original device s/n (b)(4) and therapy began.The flow rate was 1.8l/min with new pads.The system diagnostics was checked and with 4 pads attached fr=1.8l/min, ip -3psi and cp= 100%.She was guided through disconnecting and proper attachment holding blue foam tubing behind the clear clamp.Following the reconnection, the fr rose to 2.9l/min, ip -7psi and cp= 69%.Causes of heat generation were discussed (pt now 37.3c, wt= 14.5c) and following the drug protocol was advised.A bair hugger was in place.No signs of shivering or seizures were noted.
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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), used arctic gel pad medium 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 or deformities at the ends of all connectors.Zippered sample container bags were adhered to the hydrogel of the returned pads to simulate a liner replacement.Each pad was individually tested.For right thigh pad, a total of 2.07 l/min m2 of flow rate was registered during the test.The tubing was not properly secured to the pad manifold creating a hissing sound.System diagnostics were reviewed and the inlet pressure was -1.7 psi and circulation pump command was 100%.For left thigh pad, a total of 2.39 l/min m2 of flow rate were registered during the test.System diagnostics were reviewed and the inlet pressure was -7.1 psi and circulation pump command was 59%.For right chest pad, a total of 5.41 l/min m2 of flow rate were registered during the test.System diagnostics were reviewed and the inlet pressure was -7.1 psi and circulation pump command was 26% and for left chest pad, a total of 4.46 l/min m2 of flow rate were registered during the test.System diagnostics were reviewed and the inlet pressure was -7.0 psi and circulation pump command was 24%.According the test method, the flow rate was found not to be acceptable for both thigh pads.(acceptable range 2.4 l/min.M2).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: "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 2.3 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.".
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Event Description
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It was reported that an intrepid study site 132 had a normothermia patient on s/n (b)(4).A nurse walked by (she was not the patient's nurse) and heard device beeping and reported that the device was beeping and displayed a "low air leak".The flow rate was 0.8l/min and then dropped to 0l/min.The patient temperature was 36.9c, the water temperature was 12c.The event log showed an alert 01 (patient line open) multiple times and an alert 02 (low flow).The trend indicator showed 2 arrows up.She reported that she disconnected and reconnected the pads to straighten out some bends/kinks.After re-connection the device began beeping, and displayed a"low air leak" and "pt line open".Four medium pads were in place.An attempt was made to restart the device and the device began to prime, then the flow rate went to 0 l/min.The nurse was guided through disconnecting and reconnecting the pads properly.The device attempted to prime once more and the flow rate went to 0 l/min.The nurse did not want to troubleshoot each pad.She noted that she planned change device and call back.The patient was placed on s/n dyavy089.At initiation, the device attempted to prime and the flow rate went to 0 l/min.She noted that she will obtain new pads and return to the call have assistance with pre-conditioning the pads per their protocol.The nurse called back and reported that the pads were exchanged and the patient was placed back on the original device s/n dyavy098 and therapy began.The flow rate was 1.8l/min with new pads.The system diagnostics was checked and with 4 pads attached fr=1.8l/min, ip -3psi and cp= 100%.She was guided through disconnecting and proper attachment holding blue foam tubing behind the clear clamp.Following the reconnection, the fr rose to 2.9l/min, ip -7psi and cp= 69%.Causes of heat generation were discussed (pt now 37.3c, wt= 14.5c) and following the drug protocol was advised.A bair hugger was in place.No signs of shivering or seizures were noted.
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