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

Model Number 8100

Device Problems Break (1069); Corroded (1131); Inaccurate Delivery (2339)

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908)

Event Date 01/27/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Bd technical support troubleshoot with customer over the phone.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 that the patient was receiving infusions of propofol and norepinephrine.A new bag of norepinephrine was obtained at 1934 and administered by clinician via continuous infusion.Patient became hypertensive and tachycardic.Clinician noted the norepinephrine bag was empty.Medications were administered to control blood pressure.It was reported patient went into cardiac arrest at 2020.Cpr was administered to patient.Patient able to achieve return of spontaneous circulation (rosc), blood pressure and heart rate were able to be stabilized.

Event Description

It was reported that the patient was receiving infusions of propofol and norepinephrine.A new bag of norepinephrine was obtained at 1934 and administered by clinician via continuous infusion.Patient became hypertensive and tachycardic.Clinician noted the norepinephrine bag was empty.Medications were administered to control blood pressure.It was reported patient went into cardiac arrest at 2020.Cpr was administered to patient.Patient able to achieve return of spontaneous circulation (rosc), blood pressure and heart rate were able to be stabilized.

Manufacturer Narrative

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.

Event Description

It was reported that the patient was receiving infusions of propofol and norepinephrine.A new bag of norepinephrine was obtained at 1934 and administered by clinician via continuous infusion.Patient became hypertensive and tachycardic.Clinician noted the norepinephrine bag was empty.Medications were administered to control blood pressure.It was reported patient went into cardiac arrest at 2020.Cpr was administered to patient.Patient able to achieve return of spontaneous circulation (rosc), blood pressure and heart rate were able to be stabilized.

• 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: 16433938
• MDR Text Key: 310126273
• Report Number: 2016493-2023-121162
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2736-2020
• Patient Sequence Number: 1
• Treatment: 8015.; 8100 (4).
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 49 KG