Model Number 50000000 |
Device Problems
Inaccurate Flow Rate (1249); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2022 |
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 nurse attempted to started hypothermia with arctic sun device (s/n (b)(4)).The device would display priming and shut off.They did not troubleshoot the device and patient was switched to different device and nurse was getting alert 02(low flow).The nurse followed all instructions on the device without being able to resolve the issue.Nurse was unable to read the s/n as it was scratched off.The nurse stated that four large pads were in place and patient weighs (b)(6).As they spoke suddenly the flow rate rose and stabilized at 2.7l/min.The nurse stated that patient temperature was 36.6c, water temperature was 14c and dropping and target temperature was 33c.Mss explained that it could take several minutes to get all the air out of the lines or the pads.No room for a universal pad.The nurse reported that neither device had been used for about 2 years due to covid-19.Mss recommended the nurse to save the first set of pads in case of field assurance needed for return.Mss offered to troubleshoot arctic sun device (s/n (b)(4)) but nurse did not have time.Nurse would give the pads to their supervisor.They will call back if they need to use the arctic sun device (s/n (b)(4)) tonight or this weekend.
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Manufacturer Narrative
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Per investigator evaluation, bd has determined that this mdr event is not reportable.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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Event Description
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It was reported that nurse attempted to started hypothermia with arctic sun device (s/n 1510).The device would display priming and shut off.They did not troubleshoot the device and patient was switched to different device and nurse was getting alert 02(low flow).The nurse followed all instructions on the device without being able to resolve the issue.Nurse was unable to read the s/n as it was scratched off.The nurse stated that four large pads were in place and patient weighs 118 kgs.As they spoke suddenly the flow rate rose and stabilized at 2.7l/min.The nurse stated that patient temperature was 36.6c, water temperature was 14c and dropping and target temperature was 33c.Mss explained that it could take several minutes to get all the air out of the lines or the pads.No room for a universal pad.The nurse reported that neither device had been used for about 2 years due to covid-19.Mss recommended the nurse to save the first set of pads in case of field assurance needed for return.Mss offered to troubleshoot arctic sun device (s/n 1510) but nurse did not have time.Nurse would give the pads to their supervisor.They will call back if they need to use the arctic sun device (s/n (b)(6)) tonight or this weekend.
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Search Alerts/Recalls
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