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Model Number 50000000 |
Device Problems
Inaccurate Flow Rate (1249); Device Handling Problem (3265)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient temperature was 35.2c, the target temperature was 37.2c, and water temperature was 29.8c.Nurse was confused as to why the water temperature was so low and patient temperature was not higher.Nurse stated that they had one small universal pad on the patient.Mss had nurse to check the flow rate, and nurse stated that that it was 0.3lpm.Mss advised that if the flow rate was below 0.5lpm then the heater would not heat, and if it was below 0.9lpm the heater would be at reduced capacity.Nurse was going to look for an additional small universal pad as well as stop, empty pad, disconnect, reconnect with proper technique.
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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 patient temperature was 35.2c, the target temperature was 37.2c, and water temperature was 29.8c.Nurse was confused as to why the water temperature was so low and patient temperature was not higher.Nurse stated that they had one small universal pad on the patient.Mss had nurse to check the flow rate, and nurse stated that that it was 0.3lpm.Mss advised that if the flow rate was below 0.5lpm then the heater would not heat, and if it was below 0.9lpm the heater would be at reduced capacity.Nurse was going to look for an additional small universal pad as well as stop, empty pad, disconnect, reconnect with proper technique.
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Manufacturer Narrative
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Per additional information received, bd has determined that this mdr event is not reportable.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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Search Alerts/Recalls
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