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

Catalog Number 3570009

Device Problem No Flow (2991)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

The user facility submitted medwatch (b)(4) for this event.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a spectrum iq pump failed to infuse propofol as well as remifentanil at 114.3 ml/hour (volume and dose unknown) during therapy at the operating room.The patient was under anesthesia for an unspecified procedure and it was reported that during the procedure, the patient was observed to be moving and the anesthetic level was deepened with propofol (bispectral index monitoring was in progress and at appropriate levels for a general anesthetic throughout the case).After troubleshooting, it was determined that the remifentanil infusion was not actually infusing, despite having been properly programmed and starting the pump.The staff watched to make sure the pump was 'infusing: on the screen, however, verified that no drips were actually falling into the chamber.No medication appeared to have left the intravenous (iv) bag.The iv tubing and bag were removed from the pump and started on another infusion pump without issue.No additional information is available.

• 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: 12380086
• MDR Text Key: 268666510
• Report Number: 1314492-2021-03171
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412610900
• UDI-Public: (01)00085412610900
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 43