MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem No Flow (2991)

Patient Problems Awareness during Anaesthesia (1707); High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

The reported product is an unknown baxter access set.The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed; however, the reported event of "the propofol wasn't being delivered" is likely related to the kinked tubing.This is considered a use error.There is abundance of information in 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 occlusions.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that "the patient came out of the operating room (or) with propofol running at 60mg¿ with an unknown access set.It was further reported ¿upon arrival, the patient was waking up and was hypertensive¿.According to the reporter, ¿they had to start nitro prior to leaving¿ and the propofol was not being delivered.No alarm was generated.The tubing was found slightly kinked in the pump.At the time of this report, the patient outcome was not reported.No additional information is available.

• Brand Name: NI
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16794782
• MDR Text Key: 313813717
• Report Number: 1416980-2023-01931
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SPECTRUM IQ PUMP
• Patient Outcome(s): Required Intervention