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

Catalog Number 3570009

Device Problem Obstruction of Flow (2423)

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

Event Type  Injury  

Event Description

It was reported that "the patient came out of the operating room (or) with propofol running at 60mg¿ with a spectrum iq pump.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.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information d9, h3, h6, h7, h9 and h10: the device was received for evaluation.Functional testing was performed and did not identify any issues related to the customer reported condition.Evaluation sent the device for flow rate accuracy testing and the device passed with an error percentage of -0.07833%.Therefore, it is within the acceptable tolerance range of -5% to +5%.The device was also able to detect and run a loaded set with no errors occurring.A device history review revealed no issues that could have caused or contributed to the reported issue.The event history log review was completed and revealed that the user began an infusion of propofol at a rate of 23.1 ml/hr and a vtbi of 75 ml.An "upstream occlusion!" alarm occurred after running for 9 minutes.The user cleared the alarm and resumed the infusion.The events could indicate a potential relationship to the issue described in (b)(4), spectrum pump failure to emit an upstream occlusion alarm & under infusion.Per the spectrum iq operator's manual: "failure to fully resolve partial upstream occlusions and restarting the infusion while still occluded can cause the pump to not re-alarm as expected or to appear to be infusing normally, though it may be infusing at below the programmed rate.This may affect infusion accuracy, resulting in serious injury or death.Therefore, when an upstream occlusion alarm occurs, do not press the on/off key prior to inspecting the iv set line and resolving all occlusions." however, it is unknown if the user fully cleared the occlusion at the time of alarm and a definitive cause cannot be determined.The reported condition was not verified.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 60073 ; 2242702068
• MDR Report Key: 16794674
• MDR Text Key: 313811746
• Report Number: 1314492-2023-01417
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/29/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3570009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1314492-01/19/22-001-C
• Patient Sequence Number: 1
• Treatment: UNKNOWN ACCESS SET.
• Patient Outcome(s): Required Intervention