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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP 2; ELASTOMERIC INFUSION PUMP

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B. BRAUN MELSUNGEN AG EASYPUMP 2; ELASTOMERIC INFUSION PUMP Back to Search Results
Catalog Number 4540018-07
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Arrhythmia (1721); Diarrhea (1811); Nausea (1970)
Event Date 12/13/2023
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
 
Event Description
As reported by the user facility information by bbm sales organization in switzerland: "easypump overinfusion" according to the complainant, on (b)(6) 2023, the patient was setup on an easypump to have 3600 milligrams (mg) fluorouracil in 240 milliliters (ml) nacl 0.9% administered over 48 hours.The easypump was programmed to infuse the medication at 5 ml per hour (ml/h).However, when the patient woke up the morning of december 13th, the bag was empty.The therapy had completed after approximately 36 hours.Reportedly, the patient experienced diarrhea, nausea, and a heart rhythm disorder.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: device history record (dhr):- reviewed the dhr for batch 23g13ged91, there is no abnormality and no such defect detected at in process and at final control inspection.Sample/s evaluation: final control flow rate report of affected batch 23g13ged91 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -9.20% and -3.27%.As no complaint sample was received, further investigation is not possible.Cause : cause could not be determine.As no complaint sample was received, further investigation is not possible.Corrections/containment plans with effective date: not applicable corrective actions with effective date: not applicable justification: not confirmed.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
 
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Brand Name
EASYPUMP 2
Type of Device
ELASTOMERIC INFUSION PUMP
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun strabe 1
melsungen, 34212
GM  34212
Manufacturer (Section G)
B. BRAUN MELSUNGEN AG
carl-braun strabe 1
melsungen, 34212
GM   34212
Manufacturer Contact
jonathan severino
861 marcon blvd
allentown, PA 18109
4847197287
MDR Report Key18596252
MDR Text Key335080760
Report Number9610825-2024-00045
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/18/2024
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 Catalogue Number4540018-07
Device Lot Number23G13GED91
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/03/2024
Initial Date FDA Received01/29/2024
Supplement Dates Manufacturer Received01/03/2024
Supplement Dates FDA Received04/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/13/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age50 YR
Patient SexFemale
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