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

Model Number 35700009

Device Problems Device Alarm System (1012); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

Patient on versed drip at 2mg/hr.It was a 100mg/100ml bag.Assessed pump and stated bag due to be changed in 5 hours.After 5 hours, the volume still looked pretty full.Watched chamber and did not notice any drips falling.Pump never alarmed.New bag and tubing hung on new pump and malfunctioned pump taken out of circulation.

• Brand Name: SPECTRUM IQ
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15469819
• MDR Text Key: 300437756
• Report Number: 15469819
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• 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: 09/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other