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

Catalog Number 3570009

Device Problem Failure to Infuse (2340)

Patient Problem Underdose (2542)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received, and evaluation was completed.The event history log review was completed.A visual inspection was performed, and no abnormalities were found.The reported issue could not be reproduced during the device evaluation.The pump was tested with at 40ml/hr and 125ml/hr and found to deliver within specification.The device was determined to meet all product specifications related to the reported event.The reported device failed to infuse was not verified.Evaluation determined no action required at this time.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 dexmedetomidine during therapy.The drug solution was indicated for sedation and programmed at the rate of 4 ug/ml at the prescribed dose of 1 ug/kg/hr and was set up to be infused for greater than two hours.The pump displayed messages such as 'infusing' and 'infusion complete' but no medication was infused.Further details from the report indicate that the patient was being infused with the medication and the pump alerted that the volume of medication being infused was complete.The nurse added 20 more cc of medication to be infused over 2 hours.The sedated patient began to display restlessness and the nurse proceeded to increase the rate of infusion.The nurse then noted that the volume of medication had not changed.No drip was noted in the tubing and the pump was replaced.Follow-up with the customer reported the patient was described to experience "no patient injury, [no] medical intervention, [and no] symptom or adverse event.No additional information is available.

• Brand Name: SPECTRUM IQ INFUSION PUMP
• Type of Device: INFUSION PUMP
• 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: 10495290
• MDR Text Key: 205708200
• Report Number: 1314492-2020-02948
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 08/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other