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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG EASYPUMP® II; ELASTOMERIC INFUSION PUMP Back to Search Results
Model Number N/A
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).No sample has been returned for investigation.Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.Device history record (dhr): reviewed the dhr, there is no abnormality and no such defect detected at in process and at final control inspection.
 
Event Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): pump-flow rate-fast.
 
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Brand Name
EASYPUMP® II
Type of Device
ELASTOMERIC INFUSION PUMP
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, 34212
GM   34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4842408332
MDR Report Key8168863
MDR Text Key130479698
Report Number9610825-2018-00268
Device Sequence Number1
Product Code MEB
UDI-Device Identifier04046964448485
UDI-Public(01)04046964448485(17)220301(10)17C04GE221
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/17/2018
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 Expiration Date03/01/2022
Device Model NumberN/A
Device Catalogue Number4540008
Device Lot Number17C04GE221
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/17/2018
Distributor Facility Aware Date12/17/2018
Device Age21 MO
Event Location Nursing Home
Date Report to Manufacturer12/17/2018
Initial Date Manufacturer Received 11/19/2018
Initial Date FDA Received12/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2017
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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