MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROUND LAKE REPEATER PUMP, 220-240 VOLT; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number H938099EG

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.A visual inspection was performed and no issues were noted.The device was disassembled, and it was noted that there were no signs of burns or fire inside of the pump and there was also no electrical smell.The reported condition was not verified.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that the repeater pump hardware had an electrical smell at high speed.There was no patient involvement.No additional information is available.

• Brand Name: REPEATER PUMP, 220-240 VOLT
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8541061
• MDR Text Key: 142954901
• Report Number: 1416980-2019-02186
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412626611
• UDI-Public: (01)00085412626611
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: H938099EG
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/23/2019
• Type of Device Usage: N
• Patient Sequence Number: 1