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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 4540014
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 02/15/2024
Event Type  malfunction  
Event Description
According to the customer: when did the failure occur? during therapy an oncological patient is undergoing chemotherapy treatment.The drug is introduced into the pump and administered to the patient.The patient returns home before the end of the infusion.After completion, she returns to the clinic again for further treatment.The senior nurse of the center complained that the pump drained very quickly (in 24 hours the volume was 460 milliliters (ml).Side effect/impact of patient: increased blood pressure, vomiting, malaise.
 
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.
 
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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 Key18897481
MDR Text Key337754270
Report Number9610825-2024-00176
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/13/2024
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 Number4540014
Device Lot Number21M02GE251
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2024
Initial Date FDA Received03/13/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/02/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexFemale
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