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

Model Number 8015

Device Problems Inaccurate Flow Rate (1249); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Oversedation (1990)

Event Date 05/03/2021

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.Device was not returned to manufacturing facility.

Event Description

It was reported that the pump was originally programmed correctly under guardrails but paused due to an occlusion alarm.Once the resume button was selected the pump switched the infusion to a basic infusion at a rate of 999 ml/hr.This went unnoticed for a total of 4 minutes (17:23 to 17:27) until the patient's condition deteriorated.Interoperability was not involved as this was ordered as a one-step medication in epic.Per rn, patient occlusion alarm caused the originally programmed infusion to pause (confirmed via carefusion analytics data and key stroke report).The pump was found running at a rate of 999 ml/hr when the patient started to brady down and was hypotensive, placed on pacer and gave atropine ivp and then started levophed gtt and had another mame called.Pump was not removed from service at the time of the event.However, during investigation pump was found, removed from service, and tested by clinical engineer.No problems were identified.There was patient involvement.

Manufacturer Narrative

(b)(4).A review of the complaint history for sn (b)(4) was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record showed the device had a manufacture date of 24may2011.The review was performed from the date of manufacture to the present date (b)(6) 2021.A review of the device history record for sn (b)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the service history record for sn (b)(4) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.

Event Description

It was reported that the pump was originally programmed correctly under guardrails but paused due to an occlusion alarm.Once the resume button was selected the pump switched the infusion to a basic infusion at a rate of 999 ml/hr.This went unnoticed for a total of 4 minutes (17:23 to 17:27) until the patient's condition deteriorated.Interoperability was not involved as this was ordered as a one-step medication in epic.Per rn, patient occlusion alarm caused the originally programmed infusion to pause (confirmed via carefusion analytics data and key stroke report).The pump was found running at a rate of 999 ml/hr when the patient started to brady down and was hypotensive, placed on pacer and gave atropine ivp and then started levophed gtt and had another mame called.Pump was not removed from service at the time of the event.However, during investigation pump was found, removed from service, and tested by clinical engineering.Not problems were identified.There was patient involvement.

• Brand Name: ALARIS SYSTEM
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 12015437
• MDR Text Key: 256702670
• Report Number: 2016493-2021-54335
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: (01)10885403801518
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100(2); 8100(2)
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR