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Catalog Number UNKNOWN |
Device Problems
Display or Visual Feedback Problem (1184); Restricted Flow rate (1248); Improper Flow or Infusion (2954)
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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 the arctic sun device was getting alert 02 (low flow).The nurse had already changed the arctic gel pads.Therapy was stopped and restarted.Initial inlet pressure was -0.1psi.Then they received alert 41 (low internal flow).Flow rate stayed at 0lpm.They stopped therapy, emptied and disconnected the pads and placed device in manual control.Flow rate stayed on 0lpm, inlet pressure stayed on -0.1psi.They did not have another arctic sun device available at this time.The nurse would send this one to biomed.Per follow-up information received on 26aug2020, nurse stated they borrowed a device from a neighboring hospital and the patient was continuing therapy at this time.Initial pad set had been disposed of.First device sent to biomed.
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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 due to "low flow due to over-lamination of foam to film due to temp controller set too high, belt speed controller set too low or failed, nip roller pressure regulator set too high, upper belt temperature is > 85 deg c".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the arctic gel pads product ifus were found to be adequate based on past reviews.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 the arctic sun device was getting alert 02 (low flow).The nurse had already changed the arctic gel pads.Therapy was stopped and restarted.Initial inlet pressure was -0.1psi.Then they received alert 41 (low internal flow).Flow rate stayed at 0lpm.They stopped therapy, emptied and disconnected the pads and placed device in manual control.Flow rate stayed on 0lpm, inlet pressure stayed on -0.1psi.They did not have another arctic sun device available at this time.The nurse would send this one to biomed.Per follow-up information received on 26aug2020, nurse stated they borrowed a device from a neighboring hospital and the patient was continuing therapy at this time.Initial pad set had been disposed of.First device sent to biomed.
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Search Alerts/Recalls
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