MAUDE Adverse Event Report: CAREFUSION /CAREFUSION 303, INC. CAREFUSION ALARIS PUMP 8100; PUMP, INFUSION

Model Number 8100

Device Problems Disconnection (1171); No Display/Image (1183); Communication or Transmission Problem (2896); Improper Flow or Infusion (2954)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 11/15/2022

Event Type  Death  

Event Description

This was an 82 year old male patient with pmh significant for cad, chf, dm2, ckd, admitted with jaundice and hypoxia.The event was originally placed as a b3 due to scoring high on the discernment tool, however, i have upgraded to a b1.The patient underwent inpatient treatment and due to requiring additional therapy, he was admitted to our inpatient acute rehab.He further declined in rehab and was readmitted.Nephrology was on the case and wanted to start him on crrt requiring icu transfer.While in icu, he was hypotensive and on 2 pressors (vasopressin and levophed).He was noted to have an episode of hypotension and bradycardia in which the rn went to titrate the drips.Upon manipulation of the pumps, the channels became disconnected from the brain and the patient did not receive the pressors for approximately 20-30 seconds.The pumps were sequestered and the error log did show the error.However, it was learned this happens often and other pumps were tested in which "channel disconnect" was displayed, however, when looking at their error logs, the error does not display.This is another challenge that we found which can be detrimental in that we would have no idea which pumps are having issues if the errors are not being recorded in the error log.In the interim, the patient coded and rosc was not achieved.This occurred (b)(6) 2022.

• Brand Name: CAREFUSION ALARIS PUMP 8100
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION /CAREFUSION 303, INC.; franklin lakes NJ 07417
• MDR Report Key: 15976328
• MDR Text Key: 305499569
• Report Number: MW5113751
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White