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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. ELASTROMERIC PUMP EASYPUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number 4540050-02
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Description
When compounding sterile iv products for a number of patients over the past few weeks, the bbraun elastomeric pump easypump® ii st gravity disposable 100ml capacity 100 ml volume 100 ml / hr have leaked.This is item ¿4540046-02.The pharmacist that is verifying the final compounded product has noticed the leaking on the majority of these affected doses and therefore that dose of medication is re-compounded prior to shipping to the patient.However, a few doses were shipped to patients---the patient called to let us know that the dose has leaked and that it is not sable.The dose appears to be leaking out right where the tubing exits the elastomeric device.When compounding for a particular patient, we will often times make them 7, 14, or 21 doses (depending in if they are infusing every 24, 12, or 8 hours) and only 1 or two of those doses are leaking, the rest are not.There are various lot numbers that we have noticed leaking: 22e29ge721 (1 leaked), 22h27ge723 (1 leaked), 22b17ge2r (we have had approximately 8 leaky doses between 5 patients.
 
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Brand Name
ELASTROMERIC PUMP EASYPUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
MDR Report Key16305499
MDR Text Key309282816
Report NumberMW5114708
Device Sequence Number5
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 Unknown
Type of Report Initial
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number4540050-02
Device Catalogue Number4540050-02
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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