MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER SPECTRUM IQ PUMP; PUMP, INFUSION

Device Problems Failure to Infuse (2340); Pressure Problem (3012); Pumping Problem (3016)

Patient Problem Convulsion/Seizure (4406)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Pt was critically ill having continuous seizures.Was on propofol infusion from prior shift infusing.Seizures were not controlled and physician ordered propofol bolus, increased dose and additional medications for seizures (keppra and versed).Around 12:00 pump beeped infusion completed but bottle was full.We disconnected iv tubing from piv and it was under pressure, iv site seemed sluggish as medication had not been infusing.We took tubing out of pump and reloaded and ensured it was now infusing.Pt's seizures improved with receipt of propofol and we decreased other doses of meds.Leadership advised of this unsafe event with iv pump malfunction.Fda safety report id # (b)(4).

• Brand Name: BAXTER SPECTRUM IQ PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 14513360
• MDR Text Key: 292969892
• Report Number: MW5109917
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• 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: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic
• Patient Race: White