MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES; ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM
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Model Number 73407 |
Device Problems
Use of Device Problem (1670); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2022 |
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 that the nurse tried to troubleshoot stating that the arctic sun device kept getting air in the line alert with no flow, using normothermia therapy with a target temperature of 36c.Stated that the user already tried disconnecting and reconnecting pads, tried refilling device (no water would draw), and could not get a flow.Checked system diagnostics with device in automatic mode.Patient temperature was 39.0 c, water temperature was 7.7c, inlet pressure was -0.1psi, circulation pump command was 100 percent, mixing pump command was 100 percent, water level was 4, service hours were 10196, pump hours were 9774.Biomed walked through disconnection and reconnection of arctic gel pads with proper technique, attempted to start therapy but there was no flow.Put device in manual mode.Inlet pressure was -2.4psi.Removed fluid delivery line from back of unit, no vacuum was observed when left port occluded.Fluid delivery line was put back in place and locked.Inlet pressure increased to -5.6psi, flow rate was 3.3lpm.Arctic sun device was put back into automatic mode and resumed therapy.Flow rate was 3.3lpm, inlet pressure was -6.8psi.Biomed discussed pad coverage as well as patient very large bsa.Biomed encouraged to use of one or two universal gel pads in addition to large set of four pads.Per additional information received follow-up via phone on (b)(6) 2022, it was stated that the mss were able to help them correct the issues.The first call was determined to be a misconnection with the fluid delivery line.And second call disconnecting and reconnecting the pads corrected the issue.There was no patient injury.
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Event Description
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It was reported that the nurse tried to troubleshoot stating that the arctic sun device kept getting air in the line alert with no flow, using normothermia therapy with a target temperature of 36c.Stated that the user already tried disconnecting and reconnecting pads, tried refilling device (no water would draw), and could not get a flow.Checked system diagnostics with device in automatic mode.Patient temperature was 39.0 c, water temperature was 7.7c, inlet pressure was -0.1psi, circulation pump command was 100 percent, mixing pump command was 100 percent, water level was 4, service hours were 10196, pump hours were 9774.Biomed walked through disconnection and reconnection of arctic gel pads with proper technique, attempted to start therapy but there was no flow.Put device in manual mode.Inlet pressure was -2.4psi.Removed fluid delivery line from back of unit, no vacuum was observed when left port occluded.Fluid delivery line was put back in place and locked.Inlet pressure increased to -5.6psi, flow rate was 3.3lpm.Arctic sun device was put back into automatic mode and resumed therapy.Flow rate was 3.3lpm, inlet pressure was -6.8psi.Biomed discussed pad coverage as well as patient very large bsa.Biomed encouraged to use of one or two universal gel pads in addition to large set of four pads.Per additional information received follow-up via phone on 18jan2022, it was stated that the mss were able to help them correct the issues.The first call was determined to be a misconnection with the fluid delivery line.And second call disconnecting and reconnecting the pads corrected the issue.There was no patient injury.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue was incorrectly attached fluid delivery line.It was reported that the nurse tried to troubleshoot stating that the arctic sun device kept getting air in the line alert with no flow, using normothermia therapy with a target temperature of 36c.Stated that the user already tried disconnecting and reconnecting pads, tried refilling device (no water would draw), and could not get a flow.Checked system diagnostics with device in automatic mode.Patient temperature was 39.0 c, water temperature was 7.7c, inlet pressure was -0.1psi, circulation pump command was 100 percent, mixing pump command was 100 percent, water level was 4, service hour was 10196, pump hour was 9774.Biomed walked through disconnection and reconnection of arctic gel pads with proper technique, attempted to start therapy but there was no flow.Put device in manual mode.Inlet pressure was -2.4psi.Removed fluid delivery line from back of unit, no vacuum was observed when left port occluded.Fluid delivery line was put back in place and locked.Inlet pressure increased to -5.6psi, flow rate was 3.3lpm.Arctic sun device was put back into automatic mode and resumed therapy.Flow rate was 3.3lpm, inlet pressure was -6.8psi.Biomed discussed pad coverage as well as patient very large bsa.Biomed encouraged to use of one or two universal gel pads in addition to large set of four pads.Per additional information received follow-up via phone on 18jan2022, it was stated that the mss were able to help them correct the issues.The first call was determined to be a misconnection with the fluid delivery line.Potential causes were identified and reviewed.The device did not meet specifications, and was influenced by the reported failure.The device was in use on a patient.The serial number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "use only medivance approved cables and accessories with the arctic sun® temperature management system control module.Connect the fluid delivery line, patient temp 1 cable, patient temp 2 cable (optional) and fill tube to the back of the control module." the device was not returned.
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