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Model Number 10010483 |
Device Problems
Disconnection (1171); Insufficient Flow or Under Infusion (2182)
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Patient Problems
Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); No Code Available (3191)
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Event Date 05/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical product: central line;syringe; therapy date (b)(6) 2019.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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It was reported that a patient did not receive adequate fentanyl sedation resulting in agitation by the patient, and an increase in ventilator alarms.The patient 'nearly coded' 2 times, and became hypotensive with a systolic blood pressure in the 50's.The patient was also bradycardic in the morning with a heart rate in the 40's.In the afternoon, the patient's oxygen desaturated to the 40's.The patient was agitated with ventilator alarms despite being placed on a fentanyl drip.When the nurse checked on the patient to increase the sedation, it was noted that the fentanyl syringe was laying on top of the device (disconnected), even though the device continued to infuse without an alarm via a central line.Subsequently, the patient desaturated again and was ventilated with a resuscitator bag.It was not determined if the desaturation was from a mucus plug, or due to severe agitation and ongoing patient/vent asynchrony.The defective tubing was then run in another device without the syringe, and that device did not alarm either.Although requested, there was no further information provided regarding this event.
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Event Description
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It was reported that a patient did not receive adequate fentanyl sedation resulting in patient agitation, and increased ventilator alarms.The patient 'nearly coded' 2 times, and became hypotensive with a systolic blood pressure in the 50's.The patient was also bradycardic in the morning with a heart rate in the 40's.In the afternoon, the patient's oxygen desaturated to the 40's.The patient was agitated with ventilator alarms despite being placed on a fentanyl drip via a central line.When the nurse checked on the patient to increase the sedation, it was noted that the fentanyl syringe was laying on top of the device (disconnected), even though the device continued to infuse without an alarm.Subsequently, the patient desaturated again and was ventilated with a resuscitator bag.It was not determined if the desaturation was from a mucus plug, or due to severe agitation and ongoing patient/vent asynchrony.The defective tubing was then run in another device without the syringe, and that device did not alarm either.
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Manufacturer Narrative
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Bd syringe, fentanyl 1000 microgram/20ml.The customer¿s report of the syringe disconnection was confirmed.Visual inspection of the set noted the pump chamber upper fitment was broken off at the bottom of the vented spike of the set.Part of the spike¿s connection pivot was inside the upper fitment.Examination under magnification observed evidence of possible degradation of the acrylic surfaces.Functional testing was not performed due to the damage to the vented spike.The cause of the syringe disconnection was due to the pump chamber upper fitment being broken off at the bottom of the set¿s vented spike.The root cause of the broken upper fitment at the bottom of the vented spike was not determined.
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Search Alerts/Recalls
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