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

Catalog Number 3570009

Device Problem Filling Problem (1233)

Patient Problems Tachycardia (2095); Increased Respiratory Rate (2486); Cough (4457)

Event Date 02/08/2022

Event Type  Injury  

Event Description

It was reported that a spectrum pump under infused fentanyl solution during therapy and the patient experienced tachycardia, cough and tachypnea.At an unspecified time during the nurse's shift, the pump generated an audible alert notifying that the bag was empty.The nurse programmed additional volume to be given due to the bag looking full.At an unknown time, the nurse observed that the volume of fentanyl did not decrease over eight hours.The patient was disconnected from the set up, and the nurse noted that no drips were being released when a bolus was pushed.The pump was switched to another pump and drips were observed.The patient¿s condition stabilized.No additional information is available.

Manufacturer Narrative

The user facility submitted medwatch mw5109226 for this event.The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPECTRUM IQ INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park ave; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14643847
• MDR Text Key: 293630784
• Report Number: 1314492-2022-02377
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3570009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FENTANYL
• Patient Outcome(s): Required Intervention