MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY (BD) CAREFUSION CAREFUSION ALARIS IV PUMP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 8015

Device Problems Defective Alarm (1014); Battery Problem (2885)

Patient Problem Cardiac Arrest (1762)

Event Date 09/19/2022

Event Type  Death  

Event Description

The patient at issue needed an emergent thrombectomy following a cardiac arrest on (b)(6) 2022.Following her cardiac arrest, the patient was placed on multiple iv medications, including vasopressors, which were being infused via a bd alaris iv pump.The pump failed to sound a low battery alarm and stopped infusing medications.The patient passed away shortly thereafter.The following is a summary of the event at the time of the event, the patient was in the cath lab for a procedure, her pump was unplugged.Four drug cassettes were infusing (epinephrine, phenylephrine, norepinephrine, and d10w).Shortly after the start of the procedure, the bd alaris pump alarmed, notifying the rn that there was air in the line for the iv line running the d10w infusion, a new bag was hung, the line was primed to remove all air, and the infusion was restarted.All other drips ware running as ordered and were uninterrupted prior to the event.During the procedure, the bd alaris 8015 iv pump completely shut off and lost all of the patient's information and medication history.The rn was preparing additional medication to be hung on the infusion pump when the iv pump began alarming.The rn viewed the screen and saw a large red message box that read "battery discharged." prior to this time, the pump failed to alarm "low battery warning." further, there were no low battery messages or error messages sounded prior to the battery discharge screen.Because of the failure of the pump to alarm, there was an interruption of iv therapy.The patient's status continued its decline alter the pump failed.A code blue was called, the procedure was stopped) and the patient was transferred to the icu.The patient coded again and expired.We determined that bd alaris iv pump was unplugged from and remained on battery power for 2 hours and 26 minutes prior to the event.It had been charging for at least 13 hours prior to being unplugged.

• Brand Name: CAREFUSION ALARIS IV PUMP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY (BD) CAREFUSION
• MDR Report Key: 15550302
• MDR Text Key: 301343378
• Report Number: MW5112446
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8015
• 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
• Treatment: ALARIS IV DRUG MODULE 8100 S# (B)(4); ALARIS IV DRUG MODULE 8100 S# (B)(4); ALARIS IV DRUG MODULE 8100 S# (B)(4); ALARIS IV DRUG MODULE 8100 S# (B)(4)
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White