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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG EASYPUMP 2; ELASTOMERIC PUMPS

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B BRAUN MELSUNGEN AG EASYPUMP 2; ELASTOMERIC PUMPS Back to Search Results
Model Number 4540018-07
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2024
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
 
Event Description
According to the customer a patient underwent infusion therapy of fluorouracil on (b)(6) 2024.Reportedly the infuser leaked and spilled during use with a patient at the top part of the product, at the height of the lid which is leaking from the side.No patient complications were reported as a result of this event.
 
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Brand Name
EASYPUMP 2
Type of Device
ELASTOMERIC PUMPS
Manufacturer (Section D)
B BRAUN MELSUNGEN AG
carl-braun str. 1
melsungen, hessen 34212
GM  34212
Manufacturer (Section G)
B BRAUN MELSUNGEN AG
carl-braun str. 1
melsungen, hessen 34212
GM   34212
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key19174815
MDR Text Key341018677
Report Number9610825-2024-00319
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/24/2024
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? Yes
Device Operator Health Professional
Device Model Number4540018-07
Device Lot Number22L13GED91
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2024
Initial Date FDA Received04/24/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/13/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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