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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 Overdose (1988)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).No sample has been returned for investigation.The batch record could not be reviewed since the lot number is not known.Without the actual sample or lot number, a thorough investigation can not be performed.All available information has been forwarded to the actual manufacturer.If the sample or lot number and/or additional pertinent information becomes available, a follow up report will be filed.
 
Event Description
As reported by the user facility ((b)(4)): 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
901 marcon blvd.
allentown 18109
4847197287
MDR Report Key6202073
MDR Text Key63203939
Report Number9610825-2016-00913
Device Sequence Number1
Product Code MEB
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/23/2016,11/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number4540008
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/23/2016
Event Location Hospital
Date Report to Manufacturer12/23/2016
Date Manufacturer Received11/28/2016
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 Number1
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