Model Number 8100 |
Device Problems
Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Arrhythmia (1721); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
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Event Date 02/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Device was not returned to manufacturing facility for evaluation.
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Event Description
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Received a copy of the customer's medsun report from fda which states, ¿while performing a linen change the patient started to become acutely bradycardic and hypotensive.A dopamine drip was already primed and preprogramed on the alaris iv pump and attempted to be turned on.Immediately after attempting to turn the pump on it started alarming and saying "channel error".It was attempted to be restarted but kept alarming that it was disconnected.At this time the patient's primary pressor (vasopressin) also randomly shut off with no error message on the screen, it just abruptly stopped.The doctors arrived promptly to the bedside and gave verbal orders to administer img epinephrine iv push which was given immediately prior to the patient going into a pulseless electrical activity arrest".There was patient involvement and patient harm.
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Manufacturer Narrative
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Additional information: event attributed to, imdrf annex a, b and g grid, manufacturer narrative.A review of the complaint history for sn(b)(6) was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record showed the device had a manufacture date of 30jan2015.The review was performed from the date of manufacture to the present date 10jun2021.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the service history record for sn (b)(6) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.
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Event Description
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Received a copy of the customer's medsun report from fda which states, ¿while performing a linen change the patient started to become acutely bradycardic and hypotensive.A dopamine drip was already primed and preprogramed on the alaris iv pump and attempted to be turned on.Immediately after attempting to turn the pump on it started alarming and saying "channel error".It was attempted to be restarted but kept alarming that it was disconnected.At this time the patient's primary pressor (vasopressin) also randomly shut off with no error message on the screen, it just abruptly stopped.The doctors arrived promptly to the bedside and gave verbal orders to administer img epinephrine iv push which was given immediately prior to the patient going into a pulseless electrical activity arrest".There was patient involvement and patient harm.
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Search Alerts/Recalls
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