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

Device Problem No Flow (2991)

Patient Problems Discomfort (2330); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 05/31/2022

Event Type  malfunction  

Event Description

Patient was on a continuous fentanyl infusion, pump was cleared at change of shift and showed that volume had been infused.Patient was becoming increasingly agitated and looked uncomfortable.Proceeded to then check pump that fentanyl infusion was on and it showed pump was running, checked line but there were no drops coming out of tubing.Re-primed the tubing line and re-inserted into pump and pressed run.The pump was still showing that there were no occlusions and infusion was running, however no drops were coming out of tubing.Then after getting a new pump then the infusion began to run and patient's condition such as vitals and agitation improved.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: 14676586
• MDR Text Key: 294058722
• Report Number: MW5110268
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic
• Patient Race: White