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

Catalog Number 3570009

Device Problem Filling Problem (1233)

Patient Problem Irritability (2421)

Event Date 05/31/2022

Event Type  Injury  

Manufacturer Narrative

The user facility submitted mw5110268 for this event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during a continuous infusion of fentanyl 50 mcg/ml with a spectrum iq pump, the patient became increasingly agitated and looked uncomfortable even though the pump was cleared and showed the volume of medication had been infused.The nurse checked the pump, and it ¿showed pump running¿ and the infusion was ¿on¿.The intravenous (iv) line was checked; however, there was no flow observed in the tubing.According to the reporter, the tubing line was re-primed, reinserted into the spectrum pump and "run" was pressed.The pump continued to show the infusion was in progress.There were no occlusions and no drops coming out of the iv tubing.The spectrum pump was changed, and the infusion therapy was resumed.The patient's condition and agitation "improved".No additional information is available.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be completed.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.It cannot be determined if a device or user issue contributed to the reported event, however there is currently an open field action (fa-2021-056) associated with reinforcing proper iv line setup and undetected or delayed detection of upstream occlusions, which can lead to under-infusions, for spectrum pumps.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 ; 2242702068
• MDR Report Key: 14880990
• MDR Text Key: 295122898
• Report Number: 1314492-2022-02756
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412610900
• UDI-Public: (01)00085412610900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• 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
• Patient Outcome(s): Required Intervention