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It was reported that customer claimed that the reduced flow rate might contributed to a patient injury in this instance.They requested for an analysis of csv files in regards to a neonate pad and an alert 113 (reduced water temperature control).They discussed that the flow rate dropped to a value of less than 0.6lpm and explained reduced heater capacity led to the alert 113.No device malfunction was observed, and the device was operating as intended.Per email attachment, low flow confirmed based on patient case data.Later during therapy, the patient's temperature went below the lower limit.The alarm was going off and the device was switched.The nurse noted that the patient later passed.
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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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The reported issue was confirmed.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be occlusion of the fluid lines.However, there was insufficient information to confirm this potential root cause.Per attached case data "ml neonate", initial flow was at appropriate levels prior to the issue occurring.Water out temperature monitor and control matched water out target temperature, and patient temperature 1 was within 0.2c of patient target temperature.At 6:54 ,flow rate dropped from 1.0 to 0.5 lpm, confirming low flow.Alarm 2 occurred at this time.Inlet pressure remains consistent at -7 psi, indicating there is not an air leak or a failure with the circulation pump.At this same time point, circulation pump speed, which is controlled by the inlet pressure, reduces from 73 to 56.This drop in speed directly impacts flow rate.As patient temperature dropped, water out target temperature rose to 40c to induce warming of patient temperature.However, arctic sun device limits heater power when flow rate falls below 0.9 lpm, so at this point device will not be able to provide warm water and the water at the appropriate temperature cannot be delivered.The first alarm 113 occurs at 7:38, and therapy was stopped, then they restarted it to low flow conditions again which continued to impact the flow until the device alerted an alarm 11 for the pt being low, and then more 113s until it was switched for the second device.Per case data "ml neonate device 2", second device did not present an indication of low flow or alarms during this session of therapy.The initial arctic sun device was sent to the facilities internal clinical engineering department for evaluation.No issues were reported with the second device.Despite good faith efforts, no additional information is available.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "alarm: 02 low flow low priority alarm problem: the flow rate is less than 50% of the maximum flow rate measured since the last power on or empty pads, or the flow rate is less than 300 ml/minute.Solution: 1.Check that patient line connectors are fully seated in the fluid delivery line manifold.If indicated, reseat connectors.2.Check patient line connectors for damage that prevents connector from properly seating / sealing with manifold.If connector damage found, replace pad.3.Check that pad lines are not kinked.4.Check pads for leaks.Disconnect one pad at a time from the manifold to determine if one pad is contributing to the air leak or low flow.Wait a minimum of 45 seconds for the air to clear the line and then check to see if the flow has increased.If faulty pad found, replace faulty pad.5.To check whether a valve is leaking, reinstall the pad into a different location on the fluid delivery line manifold and wait a minimum of 45 seconds again.Alarm: 11 patient temperature 1 below low patient low priority alarm problem: in normothermia therapy: the patient temperature 1 reading is below the low patient alarm setting in normothermia settings.In hypothermia therapy: the patient temperature 1 reading is below the low patient alarm setting in hypothermia settings.Solution: if desired, adjust the low patient alarm setting in normothermia settings or hypothermia settings.Alarm: 113 reduced water temperature control low priority alarm problem: the system has detected that the water temperature has not been controlled as accurately as expected in the last 30 minutes.This situation may be temporary due to sudden patient temperature changes, interruption in water flow, or blockage of air flow by an obstruction or dirty filter.Solution: 1.Confirm that water flow is adequate.2.Confirm that air vents are not obstructed.Clean filter if dirty.3.Confirm that patient temperature control is stable.4.If this alarm recurs or patient temperature is not adequately controlled, consider replacing the device or discontinuing treatment.5.Contact bd customer support for troubleshooting assistance." correction: d h11: section a through f - the information provided by bd represents all 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.
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It was reported that the customer claimed the reduced flow rate might contributed to a patient injury in this instance.They requested for an analysis of csv files in regards to a neonate pad and an alert 113 (reduced water temperature control).They discussed that the flow rate dropped to a value of less than 0.6lpm and explained reduced heater capacity led to the alert 113.No device malfunction was observed, and the device was operating as intended.Per additional information received via email 26-jan-2024, low flow was confirmed based on patient case data.Later during therapy, the patient's temperature went below the lower limit.The alarm was going off and the device was switched.The nurse noted that the patient later passed.The neonatologist believed the patient's death was related to their temperature being too low and the device not correcting.Per clinical follow up via phone on (b)(6) 2024, the nicu clinical manager reported the patient passed away due to clinical, compounded high acuity reasons.She additionally stated that she did not believe the patient¿s death was due to the arctic sun device.The initial arctic sun device had alarmed twice.She was unsure if the first alarm was entirely fixed because the flow was continued and the patient appeared to be cooling as intended at that time.The esophageal probe remained in place during treatment with good positioning; placement was confirmed twice with x-ray.The second alarm could not be fixed, and the patient was placed on another device.The patient had become hypothermic/lower than protocol (below 31c) for almost an hour before being placed on the second device.The initial arctic sun device was sent to the facilities internal clinical engineering department for evaluation.No issues were reported with the second device.She stated she was unsure of how much additional information she was able to provide and requested follow up questions be sent via email.Clinical follow up questions were sent via email on (b)(6) 2024 and (b)(6) 2024 with no response received.An additional clinical follow up via phone was attempted on (b)(6) 2024 with no response received.Despite good faith efforts, no additional information is available.
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