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Model Number 8100 |
Device Problems
Crack (1135); Use of Device Problem (1670); Inaccurate Delivery (2339); Mechanics Altered (2984)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 09/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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Bd technical support troubleshoot with customer over the phone.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 programming error involving milrinone infusion.It was reported that earlier in the day, the milrinone dose had been "increased" (from 0.125 mcg/kg/min to 0.250mcg/kg/min).Later in the evening, the clinician realized that the milrinone was running for a dosing weight of "194kg" instead of actual patient weight of 88kg (or 194 lbs.).At the time the issue was discovered, the patient was reportedly at "baseline" and hemodynamically stable.As the patient was returning from the restroom to bed while being assisted by the nurse, the patient suddenly collapsed and became unresponsive.A "code" was called for cardiac arrest after the patient was found to pulseless (cardiac rhythm: pulseless electrical activity).It was reported that the critical care team performed several rounds of cardiopulmonary resuscitation (cpr).Intubation was performed and the patient eventually achieved rosc (return of spontaneous circulation).The patient was then transported to the intensive care unit (icu).
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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.Additional information : device eval by manufacturer? , reason code for no evaluation, if other specify, imdrf annex a, b, c, d, g codes and manufacturer narrative.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.H3 other text : not applicable.Device evaluated by bd.
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Event Description
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It was reported a programming error involving milrinone infusion.It was reported that earlier in the day, the milrinone dose had been "increased" (from 0.125 mcg/kg/min to 0.250mcg/kg/min).Later in the evening, the clinician realized that the milrinone was running for a dosing weight of "194kg" instead of actual patient weight of 88kg (or 194 lbs.).At the time the issue was discovered, the patient was reportedly at "baseline" and hemodynamically stable.As the patient was returning from the restroom to bed while being assisted by the nurse, the patient suddenly collapsed and became unresponsive.A "code" was called for cardiac arrest after the patient was found to pulseless (cardiac rhythm: pulseless electrical activity).It was reported that the critical care team performed several rounds of cardiopulmonary resuscitation (cpr).Intubation was performed and the patient eventually achieved rosc (return of spontaneous circulation).The patient was then transported to the intensive care unit (icu).
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Search Alerts/Recalls
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