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

Catalog Number 3570009

Device Problem Failure to Sense (1559)

Patient Problem Increased Respiratory Rate (2486)

Event Date 01/20/2021

Event Type  Injury  

Event Description

It was reported that during patient infusion of fentanyl with a spectrum iq pump, the patient experienced tachypnea, reported as" breathing rapidly" despite having increased sedatives and a fentanyl bolus.It was further reported the fentanyl wasn't flowing, even though the pump was on and had been running for 16 hours with no occlusion alarms generated.According to the reporter, the pump ¿read the fentanyl was flowing normally¿.A kink was found in the tubing above the pump that was obstructing flow.Treatment for the event was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

The device was not returned, and the serial number is unknown; therefore, a device analysis could not be completed.The likely cause of the reported event was associated with use error, related to the kinked tubing.The spectrum pump operating manual for the user to ensure that iv sets or container vents are properly functioning, that tubing clamps are in the proper positions and that tubing is free from kinks or signs of collapse outside the pump to prevent undetected upstream occlusions.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: 15485348
• MDR Text Key: 300574966
• Report Number: 1314492-2022-04137
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K220417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• 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: 08/30/2022
• 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; UNKNOWN SEDATIVES
• Patient Outcome(s): Required Intervention