BAXTER SIGMA INFUSION PUMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for BAXTER SIGMA INFUSION PUMP manufactured by Baxter Healthcare Corporation.

Event Text Entries

[181634533] During use of the hill-rom envella bed, the baxter sigma infusion pump registered an ec341 error message and stopped infusing medication. This has happened on several different occasions on different patients. In communication with hill rom and baxter concerning this issue, it was determined that the envella beds to emit higher levels of static electricity than the baxter sigma pump is rated for. There was no remediation reported by hill rom for this issue. Baxter suggested moving the infusion pumps as far away from the bed as possible and making sure the relative humidity was at least 30%. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093364
• MDR Report Key: 9769807
• Date Received: 2020-02-27
• Date of Report: 2020-02-25
• Date of Event: 2020-02-17
• Date Added to Maude: 2020-02-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BAXTER SIGMA INFUSION PUMP
• Generic Name: PUMP, INFUSION
• Product Code: FRN
• Date Received: 2020-02-27
• Model Number: SIGMA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE CORPORATION

Device Sequence Number: 2

• Brand Name: HILL-ROM ENVELLA BED
• Generic Name: BED, AIR, FLUIDIZED
• Product Code: INX
• Date Received: 2020-02-27
• Model Number: ENVELLA
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: HILL-ROM, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-27