| Catalog Number 425-00 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Burn(s) (1757)
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| Event Date 09/21/2018 |
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: comfort flo (2411-03); sticky whiskers (salter labs) qn# (b)(4).The customer was contacted via phone call by teleflex rn and email by director of r & d, global respiratory.Reporter provided the following additional information: degree of burn was unknown.Rn reported that the patient was "fussy".Necessary medical intervention detail was unknown.Patient had been discharged.Reporter also stated that he was called to the unit to assess the issue.The set-up was appropriate.Setting at 31 degrees, circuit probe-ok, device operated as intended.The device involved has not been received by the manufacturer for evaluation at the time of this report.The investigation in to this complaint is still in progress.
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Event Description
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Customer complaint states: "a patient in the nicu was receiving high flow when steam came out of the cannula from the circuit and burned the 1 week old".It was reported the patient was "treated for burns".
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Manufacturer Narrative
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Concomitant medical products : comfort flo (2411-03);sticky whiskers (salter labs)qn#1900063597 medwatch received for this event: mw5080471 the actual sample was not returned; however, the customer did provide a photo for evaluation.The reported defect could not be confirmed based on a review of the photo.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Customer complaint states: "a patient in the nicu was receiving high flow when steam came out of the cannula from the circuit and burned the 1 week old".It was reported the patient was "treated for burns".
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Manufacturer Narrative
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Continuation of concomitant medical products: comfort flo (2411-03);sticky whiskers (salter labs) (b)(4).Corrected data: section-date of event corrected to 09/21/2018.The sample was returned for evaluation.A visual exam was performed and there were no defects observed.The unit was gently rotated and then lightly shaken to determine if any loose components might be moving around inside the plastic case.Nothing loose was noted.The serial number of the unit matched the serial number reported by the customer.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Functional testing was performed and the unit was connected to 110vac.The unit passed the initial power connect test and navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.Based on the same operational parameters set in the hospital, the neptune was prepared for additional testing using the following values: rainout was set slightly to the left, toward the sun.Mode was set to non-invasive.Temperature was set to 31 c.Water source for heated moisture was a 1650 ml bottle of sterile water (product code 381-50), which was half full as reported by the hospital.The bench test setup was comprised of the following components, all of which are part of the comfort flo corrugated humidification system (product code 2416).The 2416 components used during this bench test were: 60" single limb corrugated heated-wire patient circuit, conchasmart column, and a 5psi system pressure relief valve, a conchatherm neptune dual thermistor ad (temperature monitoring set - product code 395-90) was used to monitor temperatures at the patient "y" end of the corrugated heated circuit and at the column, an infant comfort flo nasal cannula (product code 2411-03) was connected to the comfort flo heated circuit which completed the operational scenario.Two (2) liters per minute (lpm) of air pressure was placed on the system to maintain air flow through the circuit and cannula.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit functioned in this manner without any interruptions or functional anomalies for ~3.5 hours.Based on the investigation performed, the reported complaint could not be confirmed.Functional bench testing found no fault with the returned heater.The heater was operating under near similar hospital conditions during bench testing as was reported in the complaint description.
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Event Description
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Customer complaint states: "a patient in the nicu was receiving high flow when steam came out of the cannula from the circuit and burned the 1 week old".It was reported the patient was "treated for burns".
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Search Alerts/Recalls
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