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

Model Number 35700009

Device Problems Material Twisted/Bent (2981); No Flow (2991)

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

Event Date 11/02/2021

Event Type  malfunction  

Event Description

Fentanyl tubing stuck in lockbox opening, kinked off.Pump not delivering medication to the patient.Unknown if pump alarmed and if it was overridden.Fentanyl drip was never needed to be increased for comfort/sedation due to medication not being delivered by pump.Pump and tubing sequestered.Clinical engineering interrogation logs revealed one upstream occlusion alarm.Manufacturer response for iv infusion device, spectrum iq pump (per site reporter): ongoing, baxter does not have active recommendations or actions being taken to address this issue.

• Brand Name: SPECTRUM IQ
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12951904
• MDR Text Key: 281848079
• Report Number: 12951904
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• 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: 11/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other