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

Catalog Number ASKU

Device Problem Filling Problem (1233)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 01/13/2023

Event Type  Injury  

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 hypotensive critical care patient was set to receive an infusion of norepinephrine with an unknown spectrum pump.The pump was started and stopped 2-3 times and titrated (as per patient response to medication).It was further reported the patient became hypotensive.The reporter increased the rate on the pump ¿to support the patient¿s blood pressure, up to 20 mcg/min (75 ml/hr) without effect¿.The reported did not ¿notice drops coming into drip chamber¿.An upstream alarm was not generated.The tubing between the medication bag and pump was readjusted and drips were observed to be entering the chamber.The patient¿s blood pressure increased to 250/120.The pump was stopped, and the patient's blood pressure slowly returned to normal.A new pump was obtained and programmed with same tubing/bag with normal function.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 60073 ; 2242702068
• MDR Report Key: 16985848
• MDR Text Key: 315775685
• Report Number: 1314492-2023-01800
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2023
• 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: NOREPINEPHRINE; UNKNOWN ACCESS SET
• Patient Outcome(s): Other