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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EASYPUMP ELASTOMERIC INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC

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B. BRAUN MEDICAL INC. EASYPUMP ELASTOMERIC INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number 4540052-02
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 02/06/2023
Event Type  malfunction  
Event Description
During compounding in easypump 400ml - 200ml/hr size started leaking where the tubing connects to the easypump.Pump was discarded during compounding process.
 
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Brand Name
EASYPUMP ELASTOMERIC INFUSION PUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
bethlehem PA 18018 3524
MDR Report Key16380494
MDR Text Key309768997
Report NumberMW5114957
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/10/2023
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 Number4540052-02
Device Catalogue Number4540052-02
Device Lot Number22H15GE731
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/14/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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