MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERI

Catalog Number 4540018-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number: (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: event 4.Brief inquiry description: easypump infusing faster than intended detailed inquiry description: was contacted by director of pharmacy.She said that they have had at least 7 infusions with easypump finish within a 24 hr window (about twice as fast as intended) over the last 2 weeks.The total amount of easypump therapies delivered in this time period was 24.We reviewed preparation protocols and patient education.No injury reported.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERI
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18949031
• MDR Text Key: 338993917
• Report Number: 9610825-2024-00206
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4540018-02
• Device Lot Number: 23K10GE561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1