Model Number 8100 |
Device Problems
Break (1069); Corroded (1131); Excess Flow or Over-Infusion (1311)
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Patient Problems
Hypoxia (1918); Hypervolemia (2664)
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Event Date 03/26/2023 |
Event Type
Injury
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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 a pump module had an over infusion on two different patients on two different days.During the first event, a bag of 0.45% sodium chloride fluids were programmed to infuse at a rate of 50ml/hr on (b)(6) 2023 at 1524.Clinician scanned new 1 liter bag of fluid to administer on (b)(6) 2023 at 1234.Around 1530 clinician was in patient's room and noticed the 1 liter bag was near empty; she confirmed the pump was set to 50ml/hr-clinician and nurse practitioner witnessed.There was patient involvement however patient impact is unknown.The second event is captured under pr 7560383.
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Manufacturer Narrative
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Omit: b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available, a device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.
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Event Description
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It was reported a pump module had an over infusion on two different patients on two different days.During the first event, a bag of 0.45% sodium chloride fluids were programmed to infuse at a rate of 50ml/hr on 3/25/23 at 1524.Clinician scanned new 1 liter bag of fluid to administer on 3/26/23 at 1234.Around 1530 clinician was in patient's room and noticed the 1 liter bag was near empty; she confirmed the pump was set to 50ml/hr-clinician and nurse practitioner witnessed.Patient has a history of end stage renal failure and was fluid overloaded following the over infusion.Stat labs were drawn and iv lasix ordered post event.Patient declined later in the shift-several hours post infusion with increasing oxygen demands and ultimately was transferred to higher level of care in the medical intensive care unit (micu) where patient was intubated in the setting of hypoxia.Patient outcome is still pending at time of this entry as patient is currently still in the micu.The second event is captured under pr (b)(4).
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Search Alerts/Recalls
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