MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. SPECTRUM IQ; PUMP, INFUSION

Model Number 35700009

Device Problems Product Quality Problem (1506); Failure to Deliver (2338); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Propofol had been infusing all day through the same pump.Patient, propofol, and iv pump were scanned for a new bottle.The new bottle was hung.(note that the pump does not ask if there are drips falling in the chamber when the bottle is changed, only upon starting a new infusion.) rn noted no change in the amount that had left the bottle and the patient¿s blood pressure was more elevated, but the patient still remained sedated (also on fentanyl gtt).Changed the iv pump out, then immediately started seeing drops in the drip chamber.

• Brand Name: SPECTRUM IQ
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 13009770
• MDR Text Key: 282275528
• Report Number: 13009770
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35700009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other