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

Catalog Number	H938099EG
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ROUND LAKE; round lake IL
• MDR Report Key: 8541061
• Report Number: 1416980-2019-02186
• Device Sequence Number: 10841223
• Product Code: NEP
• UDI-Device Identifier: 00085412626611
• UDI-Public: (01)00085412626611
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Catalogue Number: H938099EG
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1