Model Number 26432020-1 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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The initial complaint report noted the following: our thermoflator unit was used for vein harvesting procedures on (b)(6) of 2021 (and potentially two more).The unit is in or15.Surgeon in all 3 cases was dr.(b)(6).Customer did not provide specific information on the incident.However, per the customer, the insufflator is working according to the equipment's specifications.The issue that they have identified is a potential user error with the insufflator.The user had the pressure and the flow settings much higher than he should have during the endoscopic vein harvesting.Per our complaint investigation, the customer stated: after endoscopic vein harvesting started, the patient's end tidal co2 started to rise.Anesthesia machine showed increase in etco2.Patient's blood gas showed an increase in pco2.Efforts were made to correct the co2, but it did not decrease until about 1.5 hour when endoscopic vein harvesting was finishing.Anesthesia machine settings were changed in order to lower etco2 (increase respiratory rate and changed out all hoses and filters on machine).Interventions didn't help initially.No patient impact or injury identified.Customer also stated that they are exploring user variation with co2 settings on the insufflator as a possible cause.In addition to the three cases mentioned above, customer has confirmed there were an additional two cases in (b)(6) 2021; however, they could not provide specific dates for those cases, but they believe there was no negative patient impact in those cases as well.This report is for the (b)(6) 2021 case.
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Manufacturer Narrative
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Per the evaluation findings: the flow rates and pressure readings are within manufacturing specifications.However, the comparator circuitry for pressure has drifted more then 3 places from reference.A new control board is needed.The thermoflator unit originally shipped to the customer in (b)(6) 2013 and had not been previously returned for repair or evaluation.
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Manufacturer Narrative
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Per the evaluation findings: the flow rates and pressure readings are within manufacturing specifications.However, the comparator circuitry for pressure has drifted more then 3 places from reference.A new control board is needed.The thermoflator unit originally shipped to the customer in (b)(6) 2013 and had not been previously returned for repair or evaluation.
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Event Description
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The initial complaint report noted the following: our thermoflator unit was used for vein harvesting procedures on (b)(6) of 2021 (and potentially two more).The unit is in or15.Surgeon in all 3 cases was dr.(b)(6).Customer did not provide specific information on the incident.However, per the customer, the insufflator is working according to the equipment's specifications.The issue that they have identified is a potential user error with the insufflator.The user had the pressure and the flow settings much higher than he should have during the endoscopic vein harvesting.Per our complaint investigation, the customer stated: after endoscopic vein harvesting started, the patient's end tidal co2 started to rise.Anesthesia machine showed increase in etco2.Patient's blood gas showed an increase in pco2.Efforts were made to correct the co2, but it did not decrease until about 1.5 hour when endoscopic vein harvesting was finishing.Anesthesia machine settings were changed in order to lower etco2 (increase respiratory rate and changed out all hoses and filters on machine).Interventions didn't help initially.No patient impact or injury identified.Customer also stated that they are exploring user variation with co2 settings on the insufflator as a possible cause.In addition to the three cases mentioned above, customer has confirmed there were an additional two cases in (b)(6) 2021; however, they could not provide specific dates for those cases, but they believe there was no negative patient impact in those cases as well.This report is for the (b)(6) 2021 case.
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Search Alerts/Recalls
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