MAUDE Adverse Event Report: BD HERMOSILLO, S.A. DE C.V. ENTERAL DISPENSING DEVICE PUMP; PUMP, INFUSION, ENTERAL

Device Problems Inaccurate Flow Rate (1249); Failure to Pump (1502)

Patient Problem Insufficient Information (4580)

Event Description

One of the hospitals in our system brought these events to our attention and approved having me forward the specifics to you.Bo has been notified and wanted to share with you as well.Of note there was another recent issue brought to our attention related to bo.Wrong rate of administration iv/enteral dispensing device involved iv free flow pump failure / malfunction.(b)(4).

• Brand Name: ENTERAL DISPENSING DEVICE PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): BD HERMOSILLO, S.A. DE C.V.
• MDR Report Key: 16461362
• MDR Text Key: 310585937
• Report Number: MW5115320
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2023
• Patient Sequence Number: 1