MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number 8100

Device Problems Crack (1135); Use of Device Problem (1670); Inaccurate Delivery (2339); Mechanics Altered (2984)

Patient Problem Cardiac Arrest (1762)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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).

Manufacturer Narrative

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.

Event Description

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).

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 16331509
• MDR Text Key: 309125807
• Report Number: 2016493-2023-109352
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention