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

Catalog Number ASKU

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the serial number is unknown; 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 pump had no flow of fentanyl during patient therapy.The patient was sedated on fentanyl with a new bottle hung at about 0300 at a rate of 1.5 mcg/kg/hr for a rate of 2.3 ml/hr from 0300 to 0600.The rate was decreased to 1.25 mcg/kg/hr for a rate of 1.9 ml/hr around 0600 and it was not clarified when drip was ultimately stopped.It was determined at 0200 the next morning that the fentanyl drip was not going to be reinstated and when the bottle was removed to be wasted it was noted that all 50ml were still in the bottle.There was no report of patient injury or medical intervention associated with this event.The staff clinical engineering team reviewed the pump logs and confirmed the tubing that was in use and concluded that the pump behaved as expected.The value analysis registered nurse indicated this is being communicated back to their clinical site so they can perform "education around this tubing".No additional information is available.

• Brand Name: SPECTRUM 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: 12453253
• MDR Text Key: 270811131
• Report Number: 1314492-2021-03429
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2021
• 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
• Treatment: FENTANYL; IV TUBING 2C8541