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Device Problems
Product Quality Problem (1506); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2021 |
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 arctic sun device had flow rate issues fluctuating from 0.6 lpm to 1.1 lpm in normothermia phase of therapy and noted that large arctic gel pads were in place.The initial inlet pressure (ip) was -3.7psi, circulation pump command (cpc) was 100 percentage.Pads were connected using proper technique and now the flow rate was 1.3lpm, initial inlet pressure (ip) was -3.5psi and circulation pump command (cpc) was 100 percentage.The nurse noticed two pads with a lot of bubbles and one where the blue foam tubing seemed pulled away from the clear connector.The nurse stopped therapy, restarted it and now flow rate was at 2.4lpm, initial inlet pressure (ip) was -7.2psi, circulation pump command (cpc) was 57 percentage.Nurse stated that if flow rate issues were unresolved, would grab another machine and see if the pads work on it.Also, the nurse stated that they would call the doctor and see if they could go ahead to end therapy and send the device to the biomed.System hours were 3488.
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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 "misconnection of supply and return lines".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the arctic gel pad product ifus were found to be adequate based on past reviews.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the arctic sun device had flow rate issues fluctuating from 0.6 lpm to 1.1 lpm in normothermia phase of therapy and noted that large arctic gel pads were in place.The initial inlet pressure (ip) was -3.7psi, circulation pump command (cpc) was 100 percentage.Pads were connected using proper technique and now the flow rate was 1.3lpm, initial inlet pressure (ip) was -3.5psi and circulation pump command (cpc) was 100 percentage.The nurse noticed two pads with a lot of bubbles and one where the blue foam tubing seemed pulled away from the clear connector.The nurse stopped therapy, restarted it and now flow rate was at 2.4lpm, initial inlet pressure (ip) was -7.2psi, circulation pump command (cpc) was 57 percentage.Nurse stated that if flow rate issues were unresolved, would grab another machine and see if the pads work on it.Also, the nurse stated that they would call the doctor and see if they could go ahead to end therapy and send the device to the biomed.System hours were 3488.
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Search Alerts/Recalls
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