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

Lot Number 40154633

Device Problems False Alarm (1013); Difficult or Delayed Activation (2577); Fail-Safe Problem (2936)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

Baxter pumps had to be replaced multiple times over the weekend.Unable to safely administer busulfan.Frequent alerts of upstream occlusions or air in line when there was no air in line or occlusion.Unable to administer running with proper med name, had to switch pump to basic mode in order to get the drug to flow through in the time ordered.Manufacturer response for smart infusion pump, iq infusion system (per site reporter) manufacturer has been on-site.They continue to work with the hospital.

• Brand Name: SPECTRUM IQ INFUSION SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16003777
• MDR Text Key: 305879315
• Report Number: 16003777
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 40154633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Race: White