MAUDE Adverse Event Report: IV LINE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems False Alarm (1013); Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506); Air/Gas in Device (4062)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 06/24/2023

Event Type  Death  

Event Description

Rn reported b braun iv pumps were constantly alarming "air bubble." therefore the iv medication would not infuse.Rn had normal saline connected to the patient and it was set to go for 125cc/hr but would not infuse due to "air bubble." rn troubleshooted the line by opening the iv pump and manually popping the air bubbles from the line.After multiple attempts to remove the air bubbles and thoroughly checking the line for air, the iv continued to alarm and the ns would not infuse.Rn also started a brand new line with a brand new ns bag.The pump continued to alarm air in line.Rn spent about 45 minutes troubleshooting the line until the 3rd attempt of starting a brand new iv line with ns, it finally started working correctly.The patient began to get hypotensive and tachycardic.Dr."***" ordered to start levophed.The levophed was primed and ready to infuse, however it frequently alarmed "air bubble." after 4 icu nurses troubleshooted the iv line, the pump consistently alarmed "air bubble" and would not infuse the levophed.The patients blood pressure dropped to 44/32 due to the levophed not infusing properly.A brand new levophed line was started and began to infuse properly.During the transition of switching iv lines into the pumps, the pump would take about 1-2 minutes for a new line to begin infusing.This is a harmful event since the pumps take too long to begin infusing medications while switching to a new line.Patient ultimately expired 3 days later.Unclear if death was attributed to this issue or other medical issues.Previous fda report already filed july 2022 for similar issue.Reference reports: mw5119190; mw5119192 and mw5119193.

• Brand Name: IV LINE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 17281044
• MDR Text Key: 318677287
• Report Number: MW5119191
• Device Sequence Number: 1
• Product Code: FPA
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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; Required Intervention; Other
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 82 KG