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

Model Number 35700BAX2

Device Problems Device Alarm System (1012); Pumping Problem (3016)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/07/2022

Event Type  malfunction  

Event Description

Patient is on norepinephrine and epinephrine.The norepinephrine pump was alarming "upstream occlusion".Pump was alarming upstream occlusion for a few minutes, map dropped to 30's, systolic bp dropped to 60s.There was no obvious reason for the upstream occlusion upon inspection.Htm noted: along with the complaint i noticed a se:320 before the infusion was initiated in the history log.Pump sent back to mfg.For further evaluation.

• Brand Name: SIGMA SPECTRUM INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16193994
• MDR Text Key: 307575277
• Report Number: 16193994
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412498683
• UDI-Public: 00085412498683
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 35700BAX2
• Device Catalogue Number: 35700BAX2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other