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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number 4540018-02
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Malaise (2359)
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as event six of b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Although the batch number of the device involved in the reported incident is unknown, a potential batch number of 18n02ge561 was provided.Review of the device history record performed for this batch number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.
 
Event Description
As reported by user facility: event 6.Easypump emptying 3-4 hours early when infusing 5fu.
 
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Brand Name
EASYPUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
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
861 marcon blvd.
allentown, pa 
2408332
MDR Report Key9932805
MDR Text Key195306452
Report Number9610825-2020-00080
Device Sequence Number1
Product Code MEB
UDI-Device Identifier04046964448638
UDI-Public(01)04046964448638
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/07/2020
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 Lay User/Patient
Device Model Number4540018-02
Device Catalogue Number4540018-02
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2020
Initial Date FDA Received04/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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