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

Catalog Number 3570009

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Anxiety (2328); Sedation (2368)

Event Type  Injury  

Manufacturer Narrative

The device was not received for evaluation; and the serial number is unknown therefore, a device analysis could not be completed.The spectrum system guide provides instructions to properly load an iv set and contains the following warning: "do not reverse the iv set or load the set improperly.Improper or reverse loading will result in a no flow to the patient condition, possible back flow of blood into the iv set, and occlusion or air-in-line alarms, which may interrupt therapy and cause serious injury or death.Load the iv set according to instructions in the manual." a review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

An intubated patient was waking up during the infusion of propofol with a spectrum iq pump.It was reported the patient was stable during a transfer to another hospital for treatment.While loading the intravenous (iv) set into the spectrum pump, the patient woke up and attempted to ¿jump off their bed¿.It was reported a bolus of propofol was administered; however, the patient remained awake and agitated.The nurse checked the patient¿s iv access and iv set and observed that the set had been inadvertently ¿reversibly loaded¿.It was reported that the patient "was not harmed".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 60073 ; 2242702068
• MDR Report Key: 10727676
• MDR Text Key: 212762239
• Report Number: 1314492-2020-03594
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K173084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3570009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• 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
• Patient Sequence Number: 1
• Treatment: ACCESS UNKNOWN SET; PROPOFOL
• Patient Outcome(s): Required Intervention