Model Number 8100 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Asystole (4442)
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Event Date 12/26/2021 |
Event Type
Death
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Manufacturer Narrative
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A follow up report will be submitted once the failure investigation has been completed.Per (b)(4) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
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Event Description
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Hold eb 2.17
it was reported that the pump module had a channel disconnect alarm then battery failure.It was noted that the pump module had stopped.Received a copy of the customer's medwatch report from fda which states "in afternoon, nursing noted a pump malfunction (channel disconnect error) propofol, levophed, and vasopressin were not running.Epinephrine was running in a separate functioning channel.Patient's mean arterial pressure (map's) dropped.It took approximately 30 seconds for nursing to get in the room and turn the channel pumps to turn back on, which the channels then said "battery error" and the channels shut off.With re-initiation of pump, patient's maps did not improve.The patient continued to desaturate and became bradycardic which then progressed to asystole.Resuscitation was not attempted as the patient was made dnr (do not resuscitate) earlier in the day.Given the patient's clinical condition, it cannot be determined to what effect this hastened the patient's death." it was reported that the primary and secondary causes of death were hypoxic respiratory failure secondary to covid pneumonia.
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Manufacturer Narrative
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A follow up report will be submitted once the failure investigation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
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Event Description
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It was reported that the pump module had a channel disconnect alarm then battery failure.It was noted that the pump module had stopped.Received a copy of the customer's medwatch report from fda which states "in afternoon, nursing noted a pump malfunction (channel disconnect error) propofol, levophed, and vasopressin were not running.Epinephrine was running in a separate functioning channel.Patient's mean arterial pressure (map's) dropped.It took approximately 30 seconds for nursing to get in the room and turn the channel pumps to turn back on, which the channels then said "battery error" and the channels shut off.With re-initiation of pump, patient's maps did not improve.The patient continued to desaturate and became bradycardic which then progressed to asystole.Resuscitation was not attempted as the patient was made dnr (do not resuscitate) earlier in the day.Given the patient's clinical condition, it cannot be determined to what effect this hastened the patient's death." it was reported that the primary and secondary causes of death were hypoxic respiratory failure secondary to covid pneumonia.
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Event Description
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It was reported that the pump module had a channel disconnect alarm then battery failure.It was noted that the pump module had stopped.Received a copy of the customer's medwatch report from fda which states "in afternoon, nursing noted a pump malfunction (channel disconnect error) ¿ propofol, levophed, and vasopressin were not running.Epinephrine was running in a separate functioning channel.Patient's mean arterial pressure (map's) dropped.It took approximately 30 seconds for nursing to get in the room and turn the channel pumps to turn back on, which the channels then said "battery error" and the channels shut off.With re-initiation of pump, patient's maps did not improve.The patient continued to desaturate and became bradycardic which then progressed to asystole.Resuscitation was not attempted as the patient was made dnr (do not resuscitate) earlier in the day.Given the patient's clinical condition, it cannot be determined to what effect this hastened the patient's death." it was reported that the primary and secondary causes of death were hypoxic respiratory failure secondary to covid pneumonia.
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Manufacturer Narrative
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Correction: it was determined through investigation of the returned devices that the initially reported suspect device reported is a concomitant.Please refer to manufacturer report number 2016493-2022-100366, which captured the correct suspect device per investigation report.
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Search Alerts/Recalls
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